EFRAC is an ISO 17025 accredited pharmaceutical testing facility located in Chennai, India. It has 11 regulatory accreditations and conducts a wide range of tests for drugs, cosmetics, and related products according to international standards. EFRAC utilizes cutting-edge technology and qualified instrumentation to provide precise, reliable, and legally defensible testing data to clients.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
This document is an ISO/IEC 17025:2017 audit checklist for laboratories. It contains requirements for laboratories to meet the standard in areas such as impartiality, confidentiality, organizational structure, personnel, facilities, equipment, metrological traceability, and externally provided products and services. The checklist provides the requirement, reference, status of implementation, and a comment section for each clause to help laboratories evaluate their conformance to the standard.
In this presentation you will learn about Error Proofing and their types which refers to the IATF:16949 clauses and some practical examples from the industry.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
The document discusses guidelines for food import control systems. The objective is to provide information for designing and implementing inspection programs for imported food based on food safety risks. It outlines key definitions and concepts in food import control including appropriate level of protection, audit, certification, inspection, legislation, and risk analysis. It also describes general characteristics and implementation of food import control systems such as requirements, responsibilities of competent authorities, procedures, and point of control.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
The document discusses the Production Part Approval Process (PPAP), which defines requirements for approving production parts. It covers topics like when PPAP submission is required, the requirements for part approval, submission levels and retention requirements. PPAP applies to internal and external suppliers providing bulk materials, production materials, parts or service parts. The document provides details on each of the PPAP requirements and guidelines for suppliers to follow.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
This document is an ISO/IEC 17025:2017 audit checklist for laboratories. It contains requirements for laboratories to meet the standard in areas such as impartiality, confidentiality, organizational structure, personnel, facilities, equipment, metrological traceability, and externally provided products and services. The checklist provides the requirement, reference, status of implementation, and a comment section for each clause to help laboratories evaluate their conformance to the standard.
In this presentation you will learn about Error Proofing and their types which refers to the IATF:16949 clauses and some practical examples from the industry.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
The document discusses guidelines for food import control systems. The objective is to provide information for designing and implementing inspection programs for imported food based on food safety risks. It outlines key definitions and concepts in food import control including appropriate level of protection, audit, certification, inspection, legislation, and risk analysis. It also describes general characteristics and implementation of food import control systems such as requirements, responsibilities of competent authorities, procedures, and point of control.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
The document discusses the Production Part Approval Process (PPAP), which defines requirements for approving production parts. It covers topics like when PPAP submission is required, the requirements for part approval, submission levels and retention requirements. PPAP applies to internal and external suppliers providing bulk materials, production materials, parts or service parts. The document provides details on each of the PPAP requirements and guidelines for suppliers to follow.
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
This document summarizes the ANVISA GMP guidelines for Brazil. It begins with an introduction noting that Brazil incorporates WHO pharmaceutical quality assurance guidelines into national legislation. The guidelines cover initial provisions, quality management, sterile products, computer information systems, and herbal medicines. For each section, the document compares the Brazilian guidelines to WHO guidelines, noting areas where Brazil has additional or stricter requirements. The conclusion states that in addition to generally applicable GMP stipulations, the Brazilian guidelines also address sterile products, biological and herbal products, water for pharmaceutical use, and qualification and validation.
This presentation discusses approaches for determining the number of process performance qualification (PPQ) batches needed based on a risk-based assessment of product and process knowledge and the control strategy. It describes evaluating the risks associated with product attributes, process parameters, and controls. Factors that influence risk, such as raw material variability, equipment capabilities, and process performance history are reviewed. The goal is to justify the minimum number of PPQ batches required based on the level of process understanding and control.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
The document summarizes new EU regulations on food labelling and advertising. Key points include:
- The Food Information for Consumers Regulation brings together rules on general and nutrition labelling into a single regulation.
- Mandatory labelling information such as ingredients, allergens, nutrition information, and country of origin/provenance will be extended and standardized.
- Front of package nutrition labelling options and guidelines are being considered to increase consistency and consumer understanding.
- Claims on food packages must be clear, substantiated, and pre-approved under new rules on nutrition and health claims.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Total Quality Management (TQM) is a continual process that aims to improve quality in manufacturing by reducing errors, streamlining supply chains, improving customer experience, and ensuring well-trained employees. It holds all parties accountable for quality and was developed by William Deming, influencing Japanese manufacturing. TQM focuses on internal guidelines and process standards to reduce errors, while the related Six Sigma method focuses on reducing defects.
This document is an assignment submitted by Huzaifa Naaz on the topic of releasing finished pharmaceutical products. It discusses requirements for quality control and assurance that must be met before products can be released for distribution and sale. Key aspects covered include testing for purity, potency, and stability to ensure the products meet all specifications.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
IMS Documentation Requirements As per ISO 9001,ISO 14001 and ISO 45001Global Manager Group
This document provides an overview and list of documentation included in an Integrated Management System (IMS) Documentation kit that covers requirements for ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 integration. The documentation kit includes templates for a quality manual, procedures, process flow charts, standard operating procedures, exhibits, blank sample formats, plans, policies, and audit checklists. It is intended to help users efficiently develop documentation for their own organization's IMS that complies with the relevant ISO standards.
Study on Physico- Chemical Parameters of Waste Water Effluents from Kombolcha...AI Publications
The physicochemical parameters of wastewater collected from five sampling sites were investigated. These parameters were analyzed by standard methods. The pH of the waste water varied from 4.7 to8.2, while the waste water conductivity ranges from 1205.3 to 7130.17 µScm−1. The maximum total dissolved solid was 8100mg/l.and the maximum biological oxygen demand was 2763.35 mg/l. The chemical oxygen demand of the selected samplesites varied widely (772.56–3105.13 mg/l), the nitrate content was found to be maximum insample W5 (166.00mg/l), and the sulfate content was found to be high in samples W1 andW5 (500and 4875mg/l). The chloride and sulphied contents were maximum atsamplesof W3 and W5 their concentrations were8543.45 and 10.7mg/lrespectively. Thephysicochemicalparameters studied in this work were varied between the samplesand almost all parameters studied were higher compared with the permissible limit prescribed by the United States Environmental Protection Agency and World Health Organization.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
Medicines and Healthcare products Regulatory Agency(MHRA)TMU
What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia
AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto understand their benefits and risks.
Improving public health by encouraging and facilitating developments in products that will benefit people
GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
Inspected UK Contract GMP Quality Control Laboratories.
BLUE GUIDE: Advertising and Promotion of medicines in the UK.
ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors.
Good Pharmacovigilance Practice Guide.
Guidelines on Process Validation
Guide to UK GLP Regulations 1999
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
Guide to defective medicinal products.
Introduction of a Risk Based Inspection Programme for GMP Labs.
SALIENT FEATURES, COMMITTEES/WORKING GROUPS:-
MHRA has the power to withdraw a product from market and suspend production of medicines.
A manufacturer or distributor can be prosecuted if the law has been broken.
Regulatory decisions are impartial D Different products are treated differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
NICE National Institute for Health and Clinical Excellence
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Emma Bradley from Fera Science Ltd presented on food contact materials and migration testing. Key points included:
- Migration occurs when chemicals transfer from food packaging into food and is influenced by factors like the material, substance, food, and contact conditions.
- EU legislation establishes rules for materials, substances, testing, and compliance documentation like declarations of compliance.
- Specific rules apply to plastics, which must use authorized monomers/additives and meet migration limits through testing with food simulants intended to mimic food types.
The document compares regulatory frameworks and GMP requirements between the EU and US. Some key differences include:
- EU GMP requirements are outlined in regulations, directives and guides while US requirements are in the CFR which has legal binding force.
- In the EU, the EMA and national competent authorities oversee drug approvals and inspections while in the US the FDA fulfills these roles.
- Process validation approaches have been expanded in the EU to include continuous and hybrid methods in addition to traditional approaches.
- The EU places greater emphasis on quality systems, process monitoring and product quality reviews over the lifetime of the product.
- Collaboration initiatives between the EU and US aim to further harmonize regulations and inspection processes
KRS Global Biotechnology is a leading outsourcing facility that provides the highest quality sterile and non-sterile pharmaceutical preparations. It has an unrivaled quality assurance program focusing on cGMP and USP standards. KRS is committed to developing quality processes and safety for patients through services like sterile injectables, intravenous admixtures, and topical preparations. It has a state-of-the-art analytical laboratory and uses advanced equipment to test all injectable products for sterility, potency, pH, and endotoxins to ensure the highest standards of safety and effectiveness for patients.
Diteba is a cGMP/GLP pharmaceutical laboratory located near Toronto, Canada that offers analytical R&D services including method development and validation, bioanalytical testing, quality control release testing, stability testing, and in vitro release testing. The company has over 10,000 square feet of laboratory space equipped with state-of-the-art instrumentation. Diteba's team of senior scientists have extensive experience across various therapeutic areas and analytical techniques.
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
This document summarizes the ANVISA GMP guidelines for Brazil. It begins with an introduction noting that Brazil incorporates WHO pharmaceutical quality assurance guidelines into national legislation. The guidelines cover initial provisions, quality management, sterile products, computer information systems, and herbal medicines. For each section, the document compares the Brazilian guidelines to WHO guidelines, noting areas where Brazil has additional or stricter requirements. The conclusion states that in addition to generally applicable GMP stipulations, the Brazilian guidelines also address sterile products, biological and herbal products, water for pharmaceutical use, and qualification and validation.
This presentation discusses approaches for determining the number of process performance qualification (PPQ) batches needed based on a risk-based assessment of product and process knowledge and the control strategy. It describes evaluating the risks associated with product attributes, process parameters, and controls. Factors that influence risk, such as raw material variability, equipment capabilities, and process performance history are reviewed. The goal is to justify the minimum number of PPQ batches required based on the level of process understanding and control.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
The document summarizes new EU regulations on food labelling and advertising. Key points include:
- The Food Information for Consumers Regulation brings together rules on general and nutrition labelling into a single regulation.
- Mandatory labelling information such as ingredients, allergens, nutrition information, and country of origin/provenance will be extended and standardized.
- Front of package nutrition labelling options and guidelines are being considered to increase consistency and consumer understanding.
- Claims on food packages must be clear, substantiated, and pre-approved under new rules on nutrition and health claims.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Total Quality Management (TQM) is a continual process that aims to improve quality in manufacturing by reducing errors, streamlining supply chains, improving customer experience, and ensuring well-trained employees. It holds all parties accountable for quality and was developed by William Deming, influencing Japanese manufacturing. TQM focuses on internal guidelines and process standards to reduce errors, while the related Six Sigma method focuses on reducing defects.
This document is an assignment submitted by Huzaifa Naaz on the topic of releasing finished pharmaceutical products. It discusses requirements for quality control and assurance that must be met before products can be released for distribution and sale. Key aspects covered include testing for purity, potency, and stability to ensure the products meet all specifications.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
IMS Documentation Requirements As per ISO 9001,ISO 14001 and ISO 45001Global Manager Group
This document provides an overview and list of documentation included in an Integrated Management System (IMS) Documentation kit that covers requirements for ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 integration. The documentation kit includes templates for a quality manual, procedures, process flow charts, standard operating procedures, exhibits, blank sample formats, plans, policies, and audit checklists. It is intended to help users efficiently develop documentation for their own organization's IMS that complies with the relevant ISO standards.
Study on Physico- Chemical Parameters of Waste Water Effluents from Kombolcha...AI Publications
The physicochemical parameters of wastewater collected from five sampling sites were investigated. These parameters were analyzed by standard methods. The pH of the waste water varied from 4.7 to8.2, while the waste water conductivity ranges from 1205.3 to 7130.17 µScm−1. The maximum total dissolved solid was 8100mg/l.and the maximum biological oxygen demand was 2763.35 mg/l. The chemical oxygen demand of the selected samplesites varied widely (772.56–3105.13 mg/l), the nitrate content was found to be maximum insample W5 (166.00mg/l), and the sulfate content was found to be high in samples W1 andW5 (500and 4875mg/l). The chloride and sulphied contents were maximum atsamplesof W3 and W5 their concentrations were8543.45 and 10.7mg/lrespectively. Thephysicochemicalparameters studied in this work were varied between the samplesand almost all parameters studied were higher compared with the permissible limit prescribed by the United States Environmental Protection Agency and World Health Organization.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
Medicines and Healthcare products Regulatory Agency(MHRA)TMU
What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia
AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto understand their benefits and risks.
Improving public health by encouraging and facilitating developments in products that will benefit people
GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
Inspected UK Contract GMP Quality Control Laboratories.
BLUE GUIDE: Advertising and Promotion of medicines in the UK.
ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors.
Good Pharmacovigilance Practice Guide.
Guidelines on Process Validation
Guide to UK GLP Regulations 1999
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
Guide to defective medicinal products.
Introduction of a Risk Based Inspection Programme for GMP Labs.
SALIENT FEATURES, COMMITTEES/WORKING GROUPS:-
MHRA has the power to withdraw a product from market and suspend production of medicines.
A manufacturer or distributor can be prosecuted if the law has been broken.
Regulatory decisions are impartial D Different products are treated differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
NICE National Institute for Health and Clinical Excellence
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Emma Bradley from Fera Science Ltd presented on food contact materials and migration testing. Key points included:
- Migration occurs when chemicals transfer from food packaging into food and is influenced by factors like the material, substance, food, and contact conditions.
- EU legislation establishes rules for materials, substances, testing, and compliance documentation like declarations of compliance.
- Specific rules apply to plastics, which must use authorized monomers/additives and meet migration limits through testing with food simulants intended to mimic food types.
The document compares regulatory frameworks and GMP requirements between the EU and US. Some key differences include:
- EU GMP requirements are outlined in regulations, directives and guides while US requirements are in the CFR which has legal binding force.
- In the EU, the EMA and national competent authorities oversee drug approvals and inspections while in the US the FDA fulfills these roles.
- Process validation approaches have been expanded in the EU to include continuous and hybrid methods in addition to traditional approaches.
- The EU places greater emphasis on quality systems, process monitoring and product quality reviews over the lifetime of the product.
- Collaboration initiatives between the EU and US aim to further harmonize regulations and inspection processes
KRS Global Biotechnology is a leading outsourcing facility that provides the highest quality sterile and non-sterile pharmaceutical preparations. It has an unrivaled quality assurance program focusing on cGMP and USP standards. KRS is committed to developing quality processes and safety for patients through services like sterile injectables, intravenous admixtures, and topical preparations. It has a state-of-the-art analytical laboratory and uses advanced equipment to test all injectable products for sterility, potency, pH, and endotoxins to ensure the highest standards of safety and effectiveness for patients.
Diteba is a cGMP/GLP pharmaceutical laboratory located near Toronto, Canada that offers analytical R&D services including method development and validation, bioanalytical testing, quality control release testing, stability testing, and in vitro release testing. The company has over 10,000 square feet of laboratory space equipped with state-of-the-art instrumentation. Diteba's team of senior scientists have extensive experience across various therapeutic areas and analytical techniques.
This document provides information about ZeptoMetrix Corporation, a biotechnology company that develops diagnostic tests and provides related products and services to support infectious disease research and testing. It offers purified microorganisms, serum samples, ELISA and western blot kits, and a biorepository containing over 1 million samples. ZeptoMetrix also manufactures controls, calibrators, and panels for validating diagnostic tests and has facilities for research, manufacturing, and regulatory submissions.
Good Laboratroy Practices for Pharmaceutical Laboratory.pptxnafeesa Hanif
This document is a presentation submitted by the Biochem Warriors group to Dr. Nafeesa Qudsia Hanif for the BCH-602 course. The presentation covers various topics related to pharmaceutical quality control laboratories including the role of quality control in the pharmaceutical industry, good laboratory practices, required certifications, and quality assurance and quality control processes. It is divided into several sections with group members assigned to specific topics.
Neopharm Labs provides analytical testing services including chemistry, microbiology, sterility testing, and method development and validation to the pharmaceutical, biotech, cosmetic, and veterinary industries. It has over 110 employees and 32,000 square feet of facilities in Quebec, Canada. Neopharm is certified by the FDA and Health Canada and audited by global pharmaceutical companies. It has a wide range of instrumentation and offers services such as dissolution testing, stability studies, and microbiological assays.
Micro Therapeutic Research Labs Private Limited is an integrated service provider for pharma and biotech companies. It has facilities across India including in Selaiyur, Coimbatore, Chrompet, and Padi, Chennai. The facilities include clinical pharmacology units, bioanalytical labs, preclinical and biology labs, and are GLP compliant. The company provides services across the drug development spectrum from preclinical research to clinical trials to regulatory submissions. It has experience conducting over 1000 bioavailability and bioequivalence studies for clients globally.
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
Sitec Labs provides contract research services with the vision to be a global leader in the industry through innovation and quality excellence. Their mission is to support drug discovery and development, ensure compliance with quality standards, and be a long-term trusted partner. They have over 350 staff members across two facilities totaling 75,000 square feet. Services include analytical research, impurity synthesis, bioavailability/bioequivalence studies, and regulatory compliance.
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Pharmaceutical Quality Control Laboratory.pptx..........pptxNafeesaHanif1
This document summarizes the functions of a pharmaceutical quality control laboratory. It discusses that quality control ensures manufactured products adhere to defined quality standards and are safe, effective and of good quality. The document then outlines various aspects of operating a quality control lab, including complying with good laboratory practices (GLP), good manufacturing practices (GMP) and ISO/IEC 17025. It discusses documentation, personnel, equipment, contracts, reference substances, calibration, verification, and qualifications. Finally, it summarizes procedures for sampling, testing, validating, evaluating and reporting analytical results.
The document provides information about Arbro Group, a leading manufacturer and exporter of pharmaceutical formulations in India. It has several divisions including manufacturing, research, analytical testing, and training. The Training & Development Division aims to provide quality training programs to develop skilled professionals. It offers various certificate courses on analytical techniques with both theoretical and practical components to prepare students for jobs in the growing analytical chemistry sector. The training programs are supported by the division's world-class analytical laboratory facilities and accreditations.
This document provides an overview of extractables and leachables (E&Ls) studies. It discusses that E&Ls studies are needed in industries like biomedical devices, food packaging, and pharmaceutical packaging to identify substances that can migrate from materials into products. Jordi Labs is introduced as a leader in E&Ls analysis with state-of-the-art facilities and over 80% of staff being chemists. The document outlines the basic process of an E&L study including sample selection, extractions, identification of E&Ls using techniques like mass spectrometry, quantitative analysis, and determining acceptable levels. Regulations for E&Ls from organizations like USP, FDA and ISO are also summarized.
This document discusses Good Laboratory Practices (GLP) for quality control laboratories. It defines GLP as a quality system for non-clinical health and environmental safety studies. The purpose of GLP is to promote valid and quality test data for determining safety. Key aspects of GLP include infrastructure requirements for different laboratory sections, calibration and validation of equipment, documentation standards, training programs, and safety measures. The document also provides checklists to ensure all GLP requirements are properly implemented and maintained in the quality control laboratory.
Ala Awwad Elias Kakish is a Jordanian chemist seeking a quality control position. He has over 20 years of experience in analytical chemistry and quality assurance, including working as Deputy Quality Control Manager at Sultan Medica Group and Quality Assurance Manager at PharmaquestJO. He has extensive training in ISO standards, GLP, GCP, analytical methods, and clinical research. Kakish's skills include method development, validation, sample analysis, quality control, and ensuring compliance with regulations. He aims to apply his expertise to ensure high standards, proper documentation, and regulatory compliance.
Kemwell Biopharma provides analytical services including method development and validation, characterization, testing, and stability studies for biologics such as monoclonal antibodies. They have capabilities for chromatographic and electrophoretic methods as well as bioassays. Kemwell has experience conducting long-term stability studies from 2-36 months in various temperature conditions. Their facilities include analytical instrumentation, stability chambers, and data management systems to support GMP services. Kemwell offers various partnership models including fee-for-service, risk-sharing, and strategic long-term partnerships.
This document provides summaries of ICH Q series guidelines related to pharmaceutical quality. The Q series addresses topics such as stability testing, analytical validation, impurities, pharmacopoeias, quality of biotechnological products, specifications for drug substances and products, good manufacturing practices, pharmaceutical development, quality risk management, and pharmaceutical quality systems. The guidelines provide recommendations for testing protocols, validation procedures, acceptance criteria, and ensuring quality across the lifecycle of drug manufacturing and development.
High Quality Integrated Drug R&D Servicesmedicilonz
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
Emmanuel Katto Uganda - A PhilanthropistMarina Costa
Emmanuel Katto is a well-known businessman from Uganda who is improving his town via his charitable work and commercial endeavors. The Emka Foundation is a non-profit organization that focuses on empowering adolescents through education, business, and skill development. He is the founder and CEO of this organization. His philanthropic journey is deeply personal, driven by a calling to make a positive difference in his home country. Check out the slides to more about his social work.
Bridging the Language Gap The Power of Simultaneous Interpretation in RwandaKasuku Translation Ltd
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1. DRUGS &
Edward Food Research &
Analysis Centre Limited
COSMETICS
www.efrac.org
PHARMA SERVICES
Chennai
2. Established in the 2012, EFRAC is an USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
EFRAC’s Systems & Processes ensure Precise, Reliable, Secured & Legally defensible Data of
Testing.
• USFDA Inspected Lab
• 40,000 Sq. ft. of World- Class Analytical Facility
• 11 Regulatory Accreditations & 3 International Recognitions
• Quickest Turn Around Time (TAT) in the Industry
• 21 CFR Coupled Instrumentation for Data Integrity & Security
• LIMS Platform with Barcoding & Digital Encryption Features
• Machines with Auto-samplers, Robotic Controls & DQ, IQ, OQ, PQ Qualification
• Microbiological Sections with Pressurized & Classified Clean Rooms
• Sample Pick-up Arrangements from National & International Locations
Salient Features
01
5. 04
Edward Food Research & Analysis Centre Ltd (EFRAC) is an Unique State of the Art Laboratory accreditated with ISO/IEC17025
(NABL) Standards and offers Testing Services on Scientifically well equipped Platform & International Standards to cater to the
needsoftheClientsandtheRegulatoryAuthoritieswithhighlevelofAccuracy&Precision..
Drug Administration ensuring Public Health and Hygiene is one of the Prime Concern of the Government in all Countries
around the World. One of Prerequisite for delivery of Healthcare is to ensure Integrity and Quality of Essential Drugs as per
International Standards.
Regulators likeWHO, USFDA, MHRA, CDSCO, etc sets the Global Standards for the Quality, Safety Limits, Efficacy and Purity of the
Drugsand PharmaceuticalsbothforhumanaswellasVeterinaryuse.
Laws have been laid down prescribing Stringent Measures to safeguard the Quality and Purity of Drugs & Medicines and for
recognition of theTesting Laboratories equipped with requisite Instrumentation Infrastructure with Good Laboratory Practices in
order to Safeguard and Preserve the Limits, Doses, Purity, Strength of Drugs and use of Raw Materials & other Chemical Inputs and
ReagentsofHighPurityandQualityintheManufacturingofDrugs.
InIndia, provisionshavebeenmadeintheDrugs&Cosmetics(D&C)Rules,1945asamendedin2003forApprovalofLaboratories
to carry out tests on Drugs & Raw materials used in their Manufacturing Schedule C & C (I) of Rule 150 C & Cosmetics prescribes the
Requirements criteria in terms of Area, Manpower, Equipment and Instruments of Drugs for Approval of the Drug Testing
Laboratories.
EFRAC conductsTesting for entire Range of Drug, Cosmetics Products & Raw Materials strictly following the Norms, Standards and
General Principles that have been scientifically approved by Indian Drug Regulator (CDSCO) & Internationally by WHO , USFDA,
MHRA,etc.
Entire range of DrugTesting Processes at EFRAC, strictly fulfills the International Standards and thus EFRAC ensures Safe, Secured,
Accurate,LegallyDefensibleandReliableDataonTesting.
DRUGS & COSMETICS
PHARMA SERVICES
8. Drugs & Cosmetics Division at EFRAC is an Advanced
Pharmaceutical Testing Facility. With Cutting Edge Technology,
we deliver High Quality Testing Services to the Pharmaceutical
and Cosmetics Industry. Our Cost Effective Projects and
Contractual Services, both for General and Specific Analysis
encompassing the Routine Quality Control (QC) and Research &
Development (R&D) Studies satisfies the constant Analytical
RequirementoftheIndustry.
EFRAC is managed by a Talent Pool of Experts of par Excellence
from all Fields of Professional Experience possessing
Comprehensive knowhow, Technology updates and full of
Innovative Ideas and untiring Zeal to provide Standard &
Customized Analytical Solutions as a CRO with high Levels of
Precision, Accuracy, Data Integrity & Reliability to meet the
RequirementsoftheClientandStakeHolders.
Entire Work Process at EFRAC is driven by a Robust Quality
Management System integrated online through LIMS Platform to
Track and Record the entire Laboratory Work and Data Flow and
providesrolebasedcontrols.
Our thorough understanding of Internationally Accepted cGMP
and GLP Requirements with Specialized Expertise in
State-of-the-Art Analytical Techniques combined with
unparalleled Service Support and Turn Around Time (TAT)
differentiatesusfromourCompetitors.
All the Equipments used in our Laboratories are regularly
Calibrated and Qualified as per the Current Good Laboratory
Practices (GLP) and the Requirements prescribed under the
ISO/IEC17025(NABLAccreditation).
07
9. A)THERAPEUTIC & ESSENTIAL DRUGS
a. Raw Materials/Ingredients
• Active Pharmaceutical Ingredients
(API’s)
• Inactive Ingredients or Excipients
b. Veterinary Drugs
c. Finished Products (Formulations)
d. Surgical Dressings
B) AYURVEDIC DRUGS
a. Raw Materials
• Raw Plant Materials or Herbs
• Animal Products
• Minerals and Metals
b. Finished Products (Formulations)
C) COSMETICS
a. Raw Materials
b. Finished Products
D) WATER
a. Raw Water/Potable Water
b. Purified Water
c. Water for Injection
d. Water for Haemodialysis
e. Water System Validations
E) PACKAGING MATERIAL
a.Plastic Container (Drum)
b. Glass Bottle
c.Blood Bag
d. Corrugated Box
e.Tetra Pack Material Laminate
f. PVC Bottle/Foil for Blister
g. Aluminium Foil
SPECIALIZED SERVICES
a. Stability/Shelf Life Studies
b. Extractable & Leachable Studies
c. Analytical Method Development
& Validation
d. Method Optimization and
Verification
e. Microbiological Validations
f. Antibiotics Assay
g. Forced Degradation Studies
h. Cleaning Validation
ANALYTICAL SERVICES IN DRUGS & COSMETICS
ANALYTICAL SERVICES
UPCOMING SERVICES
a.Preclinical Studies
08
PHARMA SERVICES
12. The Pharmaceutical Industry uses a very largeVariety of Raw materials and a large Array of
Ingredients is involved into the Manufacturing of a Single Product. It is often difficult, if not
impossible for a Pharmaceutical Manufacturer to have In-house Testing Facilities and
CapabilitiesforalltheIngredientsandProducts.
EFRAC's Pharma Testing Division offers a Complete Solution for Testing of Pharmaceutical
RawMaterialsincludingPharmaceuticalDrugSubstances,Intermediates,Excipientsetc.
Pharmaceuticals and related Industries require Commitment for GLP, cGMP & Stringent
QualitySystem,RobustDataIntegrityCompliancewhichEFRAChasdemonstratedoverthe
Years through its Comprehensive Setup for Testing Drugs thus ensuring Quality &
Reliability.
• IngredientTesting
• FormulationDrugTesting
• SurgicalDressing/MedicalDeviceTesting
• VeterinaryDrugsTesting
• Cosmetics/CosmeceuticalsTesting
• PharmaceuticalWaterTesting
• MicrobiologicalTesting
• AyurvedicTesting
MODERN & AYUSH DRUGS
11
14. Pharmaceutical Ingredients or the “Raw Material”, may be Natural, Semi-
Synthetic Or Synthetic Chemical Compounds or Biologically Derived
Products, which are used for Formulation of Various Dosage Forms. The
Ingredients which have Therapeutic value are referred as Active
Pharmaceutical Ingredient (API) and Ingredients which have no Therapeutic
Action but are used to formulate a Dosage Form are known as Excipients. All
Ingredients used in Formulation require Routine Analysis to ascertain the
QualityofFinishedProduct.
EFRAC's Pharma Testing wing routinely performs QC Analysis according to
CGMP Quality Standards for the APIs, Bulk Drugs, Intermediates, Excipients,
Finished Products & Packaging Materials for Systematic and Stringent
Physical, Chemical and Microbiological Analysis as per the Standardized
Validation or Pharmacopoeial Protocols to ascertain the Quality of the
FinishedProduct.
INGREDIENT TESTING
13
15. PARAMETERS
Assay (Chemical and Microbiological) • Bacterial Endotoxin Test (BET) • Boiling Point/Range • Melting
Point/Range • Clarity and Color of Solution • Congealing Temperature/Range • Distillation range • Elemental
Analysis • Enantiomeric Purity • Fatty Acid Composition • Heavy Metals (Quantitative) by AAS, ICP OES, ICP-MS •
Identification by FT-IR, Chemical Analysis etc. • Impurities and Related Substances • Limit Tests (Quantitative
Estimation) • Microbial Limit Test (MLT) • Nitrogen Estimation • Specific Optical Rotation • Particle Size
Distribution•Polymorphism•ResidualSolventsandOrganicVolatileImpurities•SensoryEvaluation•Sterility•
SteroidAssay•SulphurDioxideEstimation•Viscosity•TGAAnalysis•DSCAnalysis
METHODS
British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • Japanese Pharmacopeia • United States
Pharmacopeia
INSTRUMENTS
LC-MSMS(QQQ)•GC-(FID)•GC-(HEADSPACE,ECD,MS)•GC-MSMS(QQQ)•HPLC(FLD,PDA,ELSD,RID)•AAS–
(Flame, GTA,VGA) • ICP OES • ICP-MS •TOC Analyzer • UV -Visible Spectrophotometer • BrookfieldViscometer •
CHNS&OAnalyzer•FT-IR•IonChromatograph•Karl-FisherAutotitrator•TGA•DSC•ParticleSizeAnalyzer
14
PHARMA SERVICES
16. FORMULATION DRUG TESTING
Pharmaceutical Formulation is the Process in which Different Chemical
Substances including the Active Drugs are formulated to produce a Final
Medicinal Product. The Dosage Form or Formulation varies according to
theRouteofAdministration.
• EnteralorOral: Tablet,Capsule,OralLiquid,OralPowder
• Parental: Intravenous, Intraarterial, Intraosseous Infusion, Intra-
Muscular,Subcutaneous,Intrathecal,Intracerebroventricular,Rectal
• Topical: Epicutaneous (Cream, Lotion, Ointment, Paste), Inhalational,
Ophthalmic&OticProducts,TransdermalPatches
At EFRAC our Expert Group of Scientists can determine the Quality, Purity
and Stability of your Finished products in accordance with
Pharmacopoeial Monographs (EP, BP, USP and JP) and/or to Client
Recommended Procedures and Specifications to cater the Regulatory
RequirementsofboththeDomesticaswellasExportMarkets.
15
17. PARAMETERS
Assay (Chemical and Microbiological) • Bacterial Endotoxin Test (BET) • Boiling Point/Range
Melting Point/Range • Clarity and Color of Solution • Congealing Temperature/Range • Distillation
Range • Elemental Analysis • Enantiomeric Purity • Fatty Acid Composition • Heavy Metals
(Quantitative) by AAS, ICP OES, ICP-MS • Identification by FT-IR, Chemical Analysis • Impurities and
Related Substances • Limit Tests (Quantitative Estimation) • Microbial Limit Test (MLT)
Nitrogen Estimation • Specific Optical Rotation • Particle Size Distribution • Polymorphism • Content of
Active Ingredient • Deposition of the Emitted Dose • Description • Disintegration Test • Dissolution
Study • Osmolarity • Friability Testing • Uniformity of Content/Uniformity of Dosage Units • Residual
Solvents and Organic Volatile Impurities • Sensory Evaluation • Sterility • Steroid Assay • Sulphur
DioxideEstimation•Viscosity•TGAAnalysis•DSCAnalysis
METHODS
British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • Japanese Pharmacopeia
UnitedStatesPharmacopeia
INSTRUMENTS
LC-MSMS(QQQ)•GC-(FID)•GC-(HEADSPACE,ECD,MS)• GC-MSMS(QQQ)•HPLC(FLD,PDA,ELSD,RID)•AAS–
(Flame, GTA,VGA) • ICP OES • ICP-MS •TOC Analyzer • UV -Visible Spectrophotometer • BrookfieldViscometer •
CHNS&OAnalyzer•FT-IR•IonChromatograph•Karl-FisherAutotitrator•TGA•DSC •ParticleSizeAnalysis
16
PHARMA SERVICES
18. SURGICAL DRESSINGS/
MEDICAL DEVICES
A Surgical Dressing can have a number of Purposes depending on the Type,
Severity and Position of the Wound, although all purposes are focused
towards promoting Recovery and preventing further harm from theWound.
The Multifarious Properties desired in a Surgical Dressing i.e. Ceasing
bleeding, Absorbing Exudates, Debriding Lacerations, Accelerating Healing,
easing Physical / Psychological Trauma & preventing Infections and
Mechanical Damage necessitate Stringent Adherence to Quality Standards
asperScheduleFIIofDrugsandCosmeticsAct.
EFRAC conducts Wide Range of Quality Tests for Material & Performance
AnalysisonSurgical&AlliedProductslikeAbsorbentCottonWool,Absorbent
Gauze, Absorbent Lint, Bleached Bandage Cloth, Cloth for Plaster of Paris,
Sterilized Umbilical CottonTape, Sterilized Umbilical PolyesterTape, Surgical
Blade, Surgical Scissor, Suture & Ligature, Other Surgical Tools and render
ServicestoManufacturerstocomplywithrequisiteStandardsofScheduleFII
ofDrugsandCosmeticsAct.
17
19. METHODS
British Pharmacopeia • Drugs and Cosmetics Act and Rules. • European Pharmacopeia • Indian Pharmacopeia • Indian
Standard(IS)•ISO•ASTM•UnitedStatesPharmacopeia
INSTRUMENTS
UV -Visible Spectrophotometer • Digital Polarimeter • Digital Refractometer • Flame Photometer • Hot Air Oven •
Muffle Furnace • pH & Conductivity Meter • Refrigerated Centrifuge • Rota Evaporator •TensileTester • Compression
Tester • Bursting Strength Tester • Colorimeter • Auto Titrator • Karl Fischer Titrator • Sieve Tester • UV Chamber •
VacuumDryer
PARAMETERS
Absorbency • Acidity • Alkalinity • Colouring Matter • Ether Soluble Substances • Fluorescence
Foreign Matter • Foreign Fibres • Freedom from Optical Whitener • Identification
Penetration Test • Length & Width • Loss on Drying • Scouring Loss Percent • Sterility • Surface Active
Substances•TensileTest•Threadsperdm•WaterSolubleSubstances •Weighting/m2(GSM)
18
PHARMA SERVICES
20. Veterinary Drugs are Allopathic Medicines used within Animal Husbandry not
only to cure and prevent Diseases, but also to increase Weight Gain and
Tranquilize them during Transportation. These are group of Drugs which are
used to cater to Preventive/Curative and Promotional Healthcare of Pet,
DomesticandWildAnimals.
EFRAC performs Complete Analysis of all Contemporary Veterinary Products
like Dip Concentrates, Intra-mammary Infusions, Premixes, Veterinary
Aerosols, Veterinary Diagnostics, Veterinary Oral Liquids, Veterinary Oral
Powders, Veterinary Tablets, Veterinary Vaccines and Veterinary Parenteral
Preparations along with Analytical Method Development, Validation and
StablityStudies.
VETERINARY DRUG TESTING
19
21. 20
INSTRUMENTS
LC-MSMS(QQQ)•GC-(FID)•GC-(HEADSPACE,ECD,MS)•GC-MSMS(QQQ)•HPLC(FLD,PDA,ELSD,RID)•AAS
–(Flame,GTA,VGA)•ICPOES•ICP-MS•TOCAnalyzer•UV-VisibleSpectrophotometer•BrookfieldViscometer
•CHNS&OAnalyzer •FT-IR•IonChromatograph •Karl-FisherAutotitrator•TGA•DSC•Coulometer•Friability
Tester • HardnessTester • DisintegrationTest Apparatus • DissolutionTest Apparatus • Penetrometer • BP/MP
Apparatus•Potentiometer•ParticleSizeAnalyser
PARAMETERS
Assay (Chemical and Microbiological) • Bacterial Endotoxin Test (BET) • Boiling Point/Range • Melting
Point/Range • Clarity and Color of Solution • CongealingTemperature/Range • Distillation Range • Elemental
Analysis • Enantiomeric Purity • Fatty Acid Composition • Content of Active Ingredient • Deposition of the
Emitted Dose • Description • Disintegration Test • Dissolution Study • Osmolarity • Friability Testing •
Uniformity of Content/Uniformity of Dosage Units • Phenol in Vaccines and Antisera • Heavy Metals
(Quantitative) by AAS, ICP OES, ICP MS • Identification by FT-IR • Impurities and Related Substances • Limit
Tests (Quantitative Estimation) • Microbial LimitTest (MLT) • Nitrogen Estimation • Specific Optical Rotation •
Particle Size Distribution • Polymorphism • Residual Solvents and Organic Volatile Impurities • Sensory
Evaluation • Sterility • Steroid Assay • Sulphur Dioxide Estimation • Viscosity • TGA Analysis • DSC Analysis •
ParticleSizeAnalysis
METHODS
British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • Japanese Pharmacopeia • United
StatesPharmacopeia
PHARMA SERVICES
22. COSMETICS TESTING
A "Cosmetic Product" is any Substance or Mixture intended to be placed in
Contact with the Various External Parts of the Human Body (Epidermis, Hair
System, Nails, Lips & External Genital Organs) or with the Teeth and the
Mucous Membranes of the Oral Cavity with a purpose exclusively or mainly
Cleaning them, Perfuming them, Changing their appearance and/or
Correcting Body odors and/or Protecting them or keeping them in good
Condition.
EFRAC has wide range of Capability to analyze Varied Cosmetic Products like
Skin Care Creams, Lotions, Powders, Perfumes, Lipsticks, Fingernail &Toe Nail
Polish, Eye & Facial Make Up, Hair Removers, Permanent Waves, Colored
Contact Lenses, Hair Colors, Hair Sprays & Gels, Deodorants, Hand Sanitizer,
Baby Products, Bath Oils, Bubble Baths, Bath Salts, Butters and many other
TypesofProducts.
Cosmetic Testing Services also include a variety of Protocols on Preservation
EfficacyTests - PET (ChallengeTesting for Cosmetics), MicrobiologicalTesting,
Allergen Determination, Assays on Traces - Impurities, Patch Test, Stability
Testing for Cosmetics, Efficacy Studies, Safety Assessment, Product
Information File (PIF) Compilation and Notification to the European
Authorities(CPNP).
21
23. METHODS
JapanesePharmacopeia•UnitedStatesPharmacopeia•BritishPharmacopeia•EuropeanPharmacopeia •
IndianPharmacopeia•BureauofIndianStandards(IS) •ASTM•ISO
INSTRUMENTS
LC-MS/MS•GC-(FID/ECD/TCD/MS)•HPLC(FLD/PDA/ELSD/RID)•AAS–(Flame,GTA,VGA)•ICPOESICPMS
• IC –CD/AD/UV • Particle Size Analyzer • UV-Visible Spectrophotometer • Brookfield Viscometer •
Polarimeter • Colorimeter • Pay of Test Apparatus • Penetration Test Apparatus
ScratchTestApparatus•Tintometer•Abbe'sRefractometer•VacuumDryer
PARAMETERS
Physical Parameters (Description, Appearance, Fineness) • Sensory Evaluation • Adhesion Test
• Blush Test • Pay of Test • Scratch Test • Softening Point • Foaming Power • Alcohol Content • Assay
• Available Fluoride Ion • Calcium Thioglycolic • Cloud Temperature/Point • Colour/Clarity
• Consistency • Moisture and Volatile Matter • Dye Ingredients • Free Carbonated & Caustic Alkali
• Glycerol Content • Heavy Metals (Quantitative) • Limit Tests • Matter Insoluble in Alcohol/ Boiling
Water/ColdWater • Melting Range/Point • Nonvolatile Alcohol Soluble Mass • Particle Size of Undispersed
Pigments • Synthetic Detergent • Test for freedom from Boric Acid • Thermal Stability
• Total Fatty Substance/Matter • Viscosity • Microbiological Testing • Tests for specific Organisms
•MicrobialLimitTest(MLT)
22
PHARMA SERVICES
24. PHARMACEUTICAL
WATER TESTING
WaterplaysaCentralRoleintheProductionofPharmaceuticals.Itiswidely
usedasaRawMaterial,Ingredients&SolventsinProcessing,Formulation&
Manufacturing of Pharmaceutical Ingredients, Intermediates & Finished
Products. The most Stringent Quality Requirements apply to
Pharmaceutical Water, both as a Product Component and in Industrial
Consumption. Physico-chemical and Microbiological Quality Control are
essential for Manufacturing in accordance with GMP and are prescribed
byLaw.
EFRAC has facility for Complete Analysis of Raw Water (Potable water),
Purified water, Water for Injection, Water for Hemodialysis as per different
Pharmacopoeial and other Regulatory Requirements. EFRAC also provides
Service for Water System Validation as per USEPA, WHO, BIS, ICH, cGMP.
Apart from the Routine Testings in Water, EFRAC also offers Testing of
Dioxin,FuransandDioxinlikePCBsinWater.
23
25. METHODS
BritishPharmacopeia•EuropeanPharmacopeia •IndianPharmacopeia•JapanesePharmacopeia•United
States Pharmacopeia • WHO Guidelines • IS 10500-2012 • IS 4251-1967 • APHA • US FDA BAM • Council
Directive98/83/EC•USEPA
INSTRUMENTS
HR GC HRMS • LC-MS/MS • GC- (FID/ECD/TCD/MS) • GC-MS/P&T/HS • HPLC (FLD, PDA, ELSD, RID)
• FTIR • AAS – (Flame, GTA, VGA) • ICP OES • ICP MS • IC –CD/AD/UV • UV -Visible Spectrophotometer
•TOCAnalyzer •CHNS&OAnalyzer
PARAMETERS
Physio Chemical Parameters • Organoleptic Parameters • Minerals • Anions and Cations • Heavy Metals •
VOCs & SVOCs • Trihalomethane • Organic & Inorganic Disinfectants • Halo Acetic Acids
• PAH • PCB •Total Organic Carbon (TOC) • Pesticides (As per IS, EU, FDA,WHO, EPA) • Dioxins and Furans • All
MicrobiologicalTests(AsperIS,EU,FDA,WHO,EPA)•RadioactiveCompounds(AlphaandBetaEmitters)
24
PHARMA SERVICES
26. MICROBIOLOGICAL VALIDATIONS
Pharmaceutical Microbiology involves the Study of Microorganisms
associated with the Manufacture of Pharmaceuticals e.g. minimizing the
number of Microorganisms in a Process Environment, excluding
Microorganisms and Microbial Biproducts like Exotoxin and Endotoxin
from Water and other starting Materials, and ensuring the Finished
PharmaceuticalProductisSterile.
Microbiological Analysis is the Integral part of Pharmaceutical Analysis.
Absence of Micro-organisms or Sterility is of utmost importance in case of
all Parenteral Preparations. Environmental monitoring is necessary in all
stepsofPharmaceuticalprocessing.
EFRAC's Microbiology Laboratory is designed to meet Stringent
Regulatory Requirements with Class 10K Clean Rooms, Unidirectional
Flow, Pressure Control Devices, AHUs, Terminal HEPA Filters, Coved edges
andEpoxyFlooring.
25
27. METHODS
British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • United States Pharmacopeia • WHO Guidelines •
USEPAGuidelines•ASTM•USFDABAMMethods•ISOGuidelines
INSTRUMENTS
Auto Diluter • Smasher • Fully Automated Autoclaves Coupled with Chart Recorders & Auto Cycle Programming Feature •
Balance Integrated with Printers • Laminar Air Flow Hoods • Bio-Safety Cabinet Class A1 • LAN Integrated Bacteriological
Incubators & Hot Air Ovens Coupled With 21CFR Audit Trial Software • ELISA / Microplate Reader • Real Time PCR • Binocular
Microscope •Water Activity Meter • Laboratory Refrigerators withTemp Monitoring and Recording Features • Cold Room for
SampleStorage
PARAMETERS
Detection of Pathogens • Microbiological Method Validation • Antibiotic-Microbial assays • Microbial Limit Tests (MLT)
• Enumeration of Spoilage Micro-Flora • Residual Anti-Microbial Substances • Bacterial Enterotoxins • Bacterial EndotoxinTest
(LAL) • Sterility Testing • Mycotoxins • Bioburden Analysis, TAMC, TYMC • Microbiological Monitoring of Indoor Air
• Anti Microbial Efficacy of Medical Devices/Filters • Preservative Efficacy • Disinfection Efficacy • Potency Assays • RWCTest, SC
Test • Surgical Dressings & Medical Devices • Microbiological Assays • Microbiological Assay of Vitamins
• Membrane Filtration Method (All Bacterial and Fungal groups) • Environmental Monitoring Tests • Rodac or Settling Plates
Count • Impact Viable Air Sampler Plates Count and Identification • Gram Staining • Identification of Bacterial Species •
Identification of Fungal Species • Total Coliform E. coli • Water Heterotrophic Plate Count • Media Growth Promotion (Media
Fer tility) Testing • Growth Promotion Test- Qualitative • Growth Promotion Test- Quantitative
•HealthcareProducts&Disinfectants•EvaluationofAntimicrobialPropertiesofDifferentHealthcareProductsasperCustomer
Supplied Protocols/ASTM Methods • MIC Testing • Neutralization Testing as per ASTM 1054-02 • Antimicrobial Effectiveness
Testing of Personnel Hand Washes/Sanitizers • Germicidal value • Phenolic Disinfectants as per IS 1061 • Rideal Walker
Coefficient (R WC ) • Staphylococcus Aureus Coefficient (SAC ) • S elf- Contained BI I ndicators
•SporeStripImmersion
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PHARMA SERVICES
28. AYURVEDIC DRUGS
According to the World Health Organization (WHO), 80% of the World
Population still relies on Traditional or Herbal Medicine for their Primary
Health Care needs.The major merits ofTraditional Medicine seems to be their
perceived Efficacy, Low Incidences of Serious Side Effects and Low Cost.
Extensive & Continued usage of Traditional Medicine in the 2nd & 3rd World
Nations along with increasing Popularity of the Traditional Indian System of
MedicineWorldwide i.e Ayurveda necessitateTesting & Analysis Procedures
and StandardstobecompliantwithconcernedRegulations.
Ayurveda is the Traditional System of Indian Medicine which is regarded as
the Oldest System of Medicine in theWorld (3000 years old) that is still widely
being Practiced, especially in the Indian Subcontinent. Recently, there is
renewedinterestonAyurvedicMedicineGlobally.
Ayurvedic Drug Testing involves Testing of Ayurvedic Raw Materials (Raw
Plant, Animal & Mineral Materials, Water); and Analysis of different Ayurvedic
FormulationsorFinishedProducts(PharmacopoeiaorProprietary).
EFRAC is approved by State Drugs Control of Indian Systems of Medicine and
Homoeopathy (ISM & H) and Department of Ayurveda, Yoga & Naturopathy,
Unani, Siddha and Homoeopathy (AYUSH) & National accreditation board for
Testing and calibration laboratories (NABL) for Analysis of Ayurvedic, Siddha,
UnaniandHomoeopathicMedicinalProducts.
27
29. METHODS
Ayurvedic Pharmacopoeia of India • British Pharmacopeia • Food Chemical Codex (FCC) • United States Pharmacopeia •
Indian Pharmacopoeia • Indian Standards (IS) • Siddha Pharmacopoeia of India • Unani Pharmacopoeia of India • United
StatesPharmacopeia•WHOGuidelines
INSTRUMENTS
LC-MS MS (QQQ) • GC- (FID) • GC- (HEAD SPACE, ECD, MS) • GC-MS MS (QQQ) • HPLC (FLD, PDA, ELSD, RID) • AAS – (Flame,
GTA,VGA)•ICPOES•ICP-MS•TOCAnalyzer•UV-VisibleSpectrophotometer•BrookfieldViscometer•Coulometer•CHNS
& O Analyzer • FT-IR • Ion Chromatograph • Karl-Fisher Autotitrator • TGA • DSC • Digital Polarimeter • Friability Tester •
Hardness Tester • Disintegration Test apparatus • Dissolution Test apparatus • Penetrometer • BP/MP Apparatus •
Potentiometer
PARAMETERS
Identification (Macroscopic/Organoleptic/Sensory, Microscopic, Chemical) • Acetyl Value • Acid Insoluble Ash • Acid
Value • Adulteration with Modern Drugs/Drug Residues • Aflatoxins (Qualitative and Quantitative) • Alcohol Content &
Alcohol Soluble Extract • Analysis of Mineral Raw Materials/Metals • Assay of Marker Compounds • Boiling Point/Range •
Chromatographic Fingerprinting Studies by TLC, HPLC, GC, GC-MS, LC-MS/MS • Congealing Range/Point • Ester Value •
Ether Soluble Extractives • Fixed Oil Estimation • Fluorescence Analysis • Foreign Matter
• Heavy Metals (Qualitative and Quantitative) • Hydroxyl Value • Iodine Value • Limit Tests • Loss on Drying/Moisture
Content • Loss on Ignition • Melting Point/Range • Microbial Limit Tests and Tests for Specific Organisms • Pesticide
Residues • Powdered Herb Analysis • Protein Estimation • Essential Oil Estimation • Refractive Index & Relative Density •
Fatty Acid Profiling and Composition • Amino Acid Profiling • Sugar Estimation •Tap & Bulk density •Test for Mineral Oil •
Total Ash, ASA and Sulphated Ash • Total Phenolic Compounds • Total Solids • Total Tannins
• Unsaponifiable Matter • Viscosity • Volatile/Essential Oil Content • Water Content • Water Soluble Ash • Water Soluble
Extractive
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PHARMA SERVICES
32. ExtractablesandLeachablesareGroupofCompoundsthatcanbeofPotentRisk
and may infuse a Serious threat to Pharmaceutical Manufacturers producing
API,GenericsandFormulationEndProductsforbothDomestic&ExportMarket.
When Elements and Compounds leach into Products, from Packaging or
Manufacturing Conditions they can render them unfit and even dangerous for
use.
Leachables analysis identifies Substances which migrate from Polymeric,
Metallic or Glass Material into the patient and are typically a subset of those
identified in the Extractables Analysis. This type of Analysis is required when
there is a risk that harmful Substances may have leached into a Liquid Product,
suchasEyeDrops,fromitsContainerorPackaging.
TheAssessmentofExtractablesandLeachablesinBio-PharmaceuticalProducts
is an important step in Drug Product Development. Processing Equipment, as
well as, primary and Secondary Container Closures are Potential Vectors for
chemicalContaminants.
Extractables Analysis identifies Categorization and Quantification of
Substances which could potentially migrate from Polymeric, Metallic or Glass
Material into the Consumer's body through any of the Medicines consumed by
them during the process of treatment. It includes Monomers and Polymer
Additives such as Antioxidants, Plasticisers, Stabilizers, Dyes, Metal Catalysts &
other Harmful Chemicals which may potentially migrate into the Product under
StorageConditions.
Applicable Guidelines & Regulatory Requirements - USP <1663>, USP <1664>,
EMA - CPMP / QWP/ 4359/03, ICH - Q3A (R2), PQR5 (Mar 07, Sept 06), USFDA
GuidanceforIndustry(1992,2002)
EXTRACTABLES
AND LEACHABLES
INSTRUMENTATION
HPLC-UV, DAD • HS-GC, HS-GC-MS • GC (FID, ECD, FID-NP), GC-MS • GC-TEA
(Nitrosamines) • ICP-OES,ICP-MS,AAS,FTIR • TGA,DSC • ParticleSizeAnalyzer
31
34. ANALYTICAL METHOD DEVELOPMENT
AND VALIDATION
Non-Pharmacopoeial and Proprietary Combinations involve new Drugs and
Excipients in Multiple Combinations and require Advanced Processing /
Formulation Strategies. Thus, Product Formulation, Development and
Optimization necessitate that constituents be Accurately Determined through
ValidatedandappropriateAnalyticalMethodologies.
With the Advent of newer Drugs, Excipients & newer Processing/ Formulation
Strategies in combination with Two or more Drugs, there is a relevant need of
legitimate Analytical Methods to determine them properly. This is generally
applicable for Non-Pharmacopoeial Proprietary Combination Products and
thereforeEssentialforFormulation/ProductDevelopmentandOptimization.
EFRAC offers Economical and Strategic Solution for Method Development,
Validation, Verification, Optimization Improvement, Qualification & Transfer
Studies for a wide range of Modern Drugs, Ayurvedic Drugs, Nutraceuticals &
CosmeticProductsbycriticallyadheringtotheQualityStandards&Integritywhich
are backbone for any new Drug Delivery into the Market. Our Integrated Approach
to Analytical Method Standardization, all stages of Pharmaceutical Fabrication
Processes namely APIs, Intermediates & all types of Dosage Forms or Finished
Products has been successfully Executed in many High-Volume Projects for Clients
bymaintainingStrictDeadlines.
33
35. INSTRUMENTS
AAS – (Flame , GTA, VGA) • Digital Polarimeter • Digital Refractometer • DissolutionTest Apparatus • Flame Photometer •
FT-IR • GC- (FID) • GC- (HEAD SPACE, ECD, MS) • GC-MS MS (QQQ) • HPLC (FLD, PDA, ELSD, RID)
•IC •ICP-MS•LC-MSMS(QQQ)•Potentiometer•UV-VisibleSpectrophotometer•DSC•TGA•ParticleSizeAnalyzer
Accuracy: Closenessof TestResultstotheTrueValueacrosstheRange.
Precision: Degree of Agreement among Individual Rest Results applied repeatedly to Multiple Samples of a
HomogeneousSample.
Specificity/Selectivity:AbilitytoassesstheAnalyteinthepresenceofComponentsexpectedtobepresent.
Detection Limit (LOD): The Lowest amount of Analyte that can be Detected under the Stated Experimental
Conditions.
Quantitation Limit (LOQ): The Lowest amount of Analyte that can be determined with Acceptable Precision and
AccuracyunderthestatedExperimentalConditions.
Linearity: The ability to elicit Test Results that are Proportional to the Concentration of the Analyte within a given
Range.
Range: The Interval between the Upper and Lower Levels of Analyte that have been demonstrated to be determined
withaSuitableLevelofPrecision,Accuracy,andLinearity.
Robustness: The measure of its Capacity to remain Unaffected by Small but Deliberate Variations in Procedural
Parameters.
Studiesconducted:
Assay • Dissolution • Excipients like Preservatives and Stabilizers • Impurities and Related Substances
• Microbiological Tests • Organic Volatile Impurities and Residual Solvents • Physico-Chemical Tests • Trace Elements,
Metals,MetalloidsandHeavyMetals
34
PHARMA SERVICES
36. Cleaning Validation is the Methodology used to assure that a Cleaning Process removes
Residues of the Active Pharmaceutical Ingredients (APIs) of the Product Manufactured in a
piece of Equipment, the cleaning Aids utilized in the Cleaning Process and the Microbial
attributes to ensure that the process and processing Equipment are suitable for
Pharmaceutical Manufacturing. Potential Contaminants include Residues of the APIs, API
DegradationSpecies,orResiduesfromtheCleaningProcesssuchasDetergentsorSolvents.
All Residues are removed to Predetermined levels to ensure the Quality of the Next Product
Manufactured is not compromised by Waste from the previous Product and the Quality of
future Products using the Equipment, to prevent Cross-Contamination and as a GMP
Requirement. Acceptable Residue Limits (ARL) in Cleaning Validation is a Critical function
and should be Practically Achievable, Verifiable for Logical Determination. This covers the
Critical 10 ppm USP Limit Test on Materials for which no Toxicology Data
isavailable.
Validation of Cleaning Procedures is not normally required but a Risk Assessment should be
performed to make sure that there is no potential for Degradation or Microbial
Contamination that may adversely impact the Quality of the Product. The Analytical
Methods for Cleaning Validation should be Validated & Suitable to Quantify at the
Acceptance Criterion Level.The Limit of Detection (LOD) must be lower than or equal to the
Acceptance Criterion Level. Blanks must be evaluated to ensure that there is no significant
interferencewiththeRecoveryoftheAnalyte.
EFRAC's Cleaning Validation services include Validation of Cleaning Procedures, Challenge
Tests for Equipment Cleaning Process & Equipment specific Sampling through Visual
inspection, Swab sampling or Rinse Sampling, Limit Test or cover a range of Analyte
Concentration. The broad Cleaning Validation Sampling Techniques cover Swabbing,
Rinsing&otherappropriateorSpecificTechniques.
35
CLEANING VALIDATION
37. 36
METHODS
British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • Japanese Pharmacopeia • United
StatesPharmacopeia
INSTRUMENTS
AAS (Flame, GTA,VGA) • ICP-MS • ICP-OES • FT-IR • LC-MS MS (QQQ) • GC- (FID, HEAD SPACE, ECD, MS) • GC-MS
MS (QQQ) • HPLC (FLD, PDA, ELSD, RID) • IC –CD/AD/UV • Karl-Fisher Autotitrator
Potentiometer • Refrigerated Centrifuge • Rota Evaporator •TOC Analyzer • UV -Visible Spectrophotometer •
RT-PCR•ELISAReader
PARAMETERS
Organic Ingredient Residue • Inorganic Ingredient Residue • Microbial Contaminants • Toxic Organic Volatile
Impurity
PHARMA SERVICES
39. 38
Antimicrobial Preservatives are Substances added to Products to protect them from
Microbiological Growth or from Micro-organisms that are introduced inadvertently
during or subsequent to the Manufacturing Process.They deter occurrence of Ingress
or Growth of Micro-organisms during/ after Manufacture or subsequently, during
handling of Multiple-Dose Containers. Microbes can cause the Product to spoil, thus
reducing its Shelf-Life, but more importantly the Potential for Contamination with
Potentially Pathogenic Strains, i.e. those that cause Disease and are dangerous to end
users, can greatly increase in the Absence of Preservatives. Cosmetics are well known
for their ability to Support Microbial Growth. Water-based Products with a Neutral pH
have shown to be the most Susceptible. In the case of Products Packaged in Multiple-
DoseContainers,AntimicrobialPreservativesareaddedtoinhibittheGrowthofMicro-
OrganismsthatmaybeintroducedfromrepeatedlywithdrawingIndividualuseDoses.
Efficacy Testing is especially an Area that highlights EFRAC's Expertise. We perform
routine Preservative Efficacy Testing for wide Range of Cosmetics & Personal Care
Products as per different PharmacopoeiaswellasclientssharedMethods.
PRESERVATIVE EFFICACY TESTING
PHARMA SERVICES
41. Sterile Pharmaceutical and Medical Device Manufacturing Environments require an
effective Cleaning and Disinfection Program to maintain Aseptic Conditions and
preventtheMicrobialContaminationoftheProduct.TheQualificationoftheChemical
Disinfectants used in these Environments is extremely important, yet it is often
overlooked.
There are a number of Methods for qualifying a Disinfectant published by the
Association of Official Analytical Chemists (AOAC), yet these are for qualifying the
Disinfectant itself. Efficacy Testing is the actual testing of the Disinfectant. As per the
USP General Chapter <1072> Disinfectants, the Test system is inoculated with
sufficientinoculumtodemonstrateatleasta2logReductionforBacterialSporesanda
3 log Reduction for Vegetative Bacteria and allowed to dry. The Inoculated System is
then exposed to the desired Concentration of the Disinfectant for the desired Contact
Time. The surviving Population in the Test system is determined and the log10
ReductionisCalculated.
We at EFRAC offer a Wide Range of Testing Services for Disinfectants using ASTM, EPA
and Pharmacopoeial methods.The passing Criteria depends on the method used and
theLabelClaimdesired,butistypicallyapercentReductionsuchas99.9%.
DISINFECTANT EFFICACY TESTING
40
PHARMA SERVICES
42. 41
The Antibiotic PotencyTest measures the Bioactivity or Potency of various Antibiotics. All
AntibioticsmustgothroughPotencyTestingpriortoMarketRelease.
In the Antibiotic Potency Test Procedure, Cultures are grown and adjusted using
Turbidimetric MeasurementTechniques. An Aliquot of the adjusted Culture is added to a
Thin Layer of Agar to create a Seed Layer. Test Samples are diluted to an appropriate Test
Concentration according to Labeled Potency Claims. A Reference Standard Antibiotic is
diluted in a similar manner with several Dilutions used to create a
StandardCurve.
The Sample Potency is estimated by averaging the Reference Standard Zone Diameters
and the Sample Zone diameters on the Three Plates used. Concentrations are calculated
fromthecorrespondingCorrectedValuesofZoneDiameters.ThelogValueisconvertedto
the antilog. The antilog Value is multiplied by the Dilution Factor to obtain the
Concentration in mg/ml of Active antibiotic.These Calculations are done with aValidated
SpreadsheetforAntibioticPotency.
EFRAC has experience inTesting various Antibiotics in compliance with the Cylinder Plate
Method as per different Pharmacopoeias IP, BP, USP General Chapter on Antibiotics-
MicrobialAssays.
ANTIBIOTIC ASSAY
45. 44
Refrigerated Condition
Primary ICH Long Term Condition (For Zone I to II)
Intermediate ICH Condition (For Zone Ivb)
Intermediate ICH Condition (For Zone I to Iva)
Accelerated ICH Condition (For Zone I to IV)
ICH Option 1 and 2 with Iight Intensity Recording
*Custom Storage Conditions can be Programmed to meet Client Requirements.
5°C
25°C/
60% R.H
30°C /
75% RH
30°C /
60% RH
40°C /
75% RH
Photo
stability
STABILITY STUDIES
MoleculesdeemedpromisingasProbableCandidatesforAPI/PharmaceuticalFormulation
during the Drug Discovery Process are exposed to Stability Testing, which is Integral to
develop New Drug Candidates i.e., APIs and Pharmaceutical Formulations/Products for
establishing their Shelf Life or Expiry Date. Influence or possible interaction of Packaging
MaterialwithDrugProductsduringShelfLifePeriodshouldalsobestudied.
It is also important during Routine Manufacturing Process to monitor Product Quality with
respecttoTimeandEnvironmentalConditions.
As per ICH Guidelines our Stability Storage Facility is equipped with Stability Chambers
controlled by 21 CFR Part 11 Requirements with Online Temperature and RH Data
Recording, Auto Alarm and Mobile Text Warning Facilities. We cover a wide range of
EnvironmentalConditionssuchas:
PHARMA SERVICES
47. 46
FORCED DEGRADATION STUDY
Forced Degradation Study (or StressTesting) typically involves Exposure of Drug Substances
or Formulations thereof to Environmental Stress Conditions namely Heat and Humidity and
Light for Solid-State Studies. For Liquid State Studies the Drug Substance/Formulation is
exposed to a range of pH values, Freezing and Thawing. It is also referred as Accelerated
StabilityStudy.
Degradation Type
Acid
Base
Oxidation
Photolysis
Thermal
Metal Ions
Humidity
Experimental Conditions
0.1 N Hydrochloric Acid
0.1 N NaOH
3 % Hydrogen Peroxide
UV Lamp
Heat Chamber
0.05 M Fe or Cu
2 2
Stability Chamber
Condition
Ambient
Ambient
Ambient
Ambient
60°C
Ambient
75 % RH or Greater
InICHQ1A,Section2.1.2(StressTesting),therearerecommendedConditionsforperforming
Forced Degradation Studies on Drug Substances (API) and Drug Products (Formulations).
The Recommendations are to examine the Effects of Temperature (above that for
AcceleratedTesting,i.e.,>50°C),Humidity(≥75%RelativeHumidity),Oxidation&Photolysis.
ICH Q1B gives recommended approaches to assess the Photo stability of Drug Substances
and Drug Products. Forced Degradation Conditions are specified in Section II (Drug
Substance) and Section III (Drug Product). Photo stability Testing can be performed on the
SolidorinSolution/Suspension.
EFRAC has proven Competency and Adequate Capacity to undertake all such Degradation
StudiesacrossVariousDrugMatrices.
PHARMA SERVICES
50. Before a new Active Substance can be used as a Medicinal Product, it has to be tested for its
Safety and Efficacy in Animals prior to its use in Humans.This testing in Animals is termed as
Pre-Clinical Studies. Preclinical Studies are conducted to define the Pharmacological and
Toxicological Effects not only prior to initiation of Human Studies but throughout the
Clinical Drug Development Process. In general, Pre-clinical studies are performed to predict
the Safety and Efficacy Data from the Animal Models which support the conduct of research
inHumanBeings.ThePre-ClinicalStudiesalsomustgetapprovalbyRegulatoryAuthorities.
A. PHAMACOLOGICALSTUDIES
Pharmacology deals with the Pharmacokinetic and Pharmacodynamic Properties of Drug. It
is important to investigate undesirable Pharmacological Activity in appropriate Animal
Models and Monitoring them in Toxicological Studies. Pharmacokinetic Studies are very
important to reveal the Safety and Efficacy Parameters in terms of Absorption, Distribution,
Metabolism & Excretion (ADME). These Studies give data on Absorption Rate for different
Routes of Administration, which helps in dosage form Selection, Distribution Mechanism,
RateofMetabolismandExcretion;whichdeterminestheHalf-LifeoftheDrug.
B. TOXICOLOGICALSTUDIES
Toxicological Activity of the Products can be determined using in-vitro and in-vivo Assay
Methods which estimate the Clinical relatedness of theToxicological Effects of the Drug. In-
vitro studies can be performed to examine the direct effects on Cellular Phenotype and
Proliferation. In-vivo studies can be performed for Qualitative and Quantitative
determination of Toxicological effects. In-vivo studies to assess Pharmacological and
Toxicological activities, including defining Mechanism(s) of Action, are often used to
supporttherationaleoftheproposeduseoftheproductinClinicalStudies.
EFRAC shall set up Infrastructure for conducting Toxicology studies in accordance with
National and International Regulatory Guidelines and GLP Standards (i.e., FDA, OECD, EPA-
OCSPP, ICH, CPSEA, EU, JMAFF) & shall engage a Pool of Staff of experienced experts for
designing Customized Studies to meet the specific needs of our Clients.These include Non-
GLPScreeningStudieswhichcanbeutilizedtoCost-EffectivelyevaluatePrototypes.
PRECLINICAL STUDIES
49
51. GUIDELINE
21CFRPart58.1GoodLaboratoryPracticeforNon-ClinicalLaboratoryStudies
PARAMETERS
Adrenocorticotrophic Hormone Assay • Gonadotrophic Hormone for LH Activity • FSH Activity •
Glucagon Activity • Depressor or Histamine like substance • Pyrogen Test • Safety Test • Biological
Reactivity Test • Determination of Lethal Doses, LD10 or LD 50 in Albino Mice • Skin Sensitivity/Eye
Irritation • ImplantationTest • PotencyTesting of RabiesVaccine • PotencyTesting of Pertussis fraction on
DPT vaccine • Potency Testing of Tetanus Fraction of DPT/DT/IT Vaccine • Potency Testing of Diphtheria
fractionofDPT/DTVaccine•TestingofOralPolioVaccine(OPV)•PotencyTestingofJapaneseEncephalitis
Vaccine•PotencyTestingofSnakeVenomSerum(AVS)
50
PHARMA SERVICES