The document provides information on documentation in the pharmaceutical industry including:
1. It emphasizes the importance of documentation for industries and describes protocols regarding documentation and their management.
2. Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. It provides a route for auditors to assess quality operations.
3. The most common types of documents used for GMP are described, including quality manuals, standard operating procedures, batch records, test methods, and specifications.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
Documentation of technology Transfer .pptxParthRana47
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
SUPAC, BACPAC, Post Marketing SurveillanceMANIKANDAN V
This document discusses various guidelines related to product development and technology transfer in the pharmaceutical industry. It covers SUPAC, BACPAC, and post-marketing surveillance. SUPAC provides guidance for scale-up and post-approval changes, categorizing changes into different levels based on their potential impact. BACPAC guidance addresses post-approval changes for bulk active pharmaceutical ingredients. Post-marketing surveillance involves monitoring adverse drug events after approval to ensure ongoing safety and effectiveness.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
This document provides an overview of spheronization as a process for producing spherical pharmaceutical granules. It defines spheronization and discusses the key advantages such as improved flow properties and uniform packing. The document describes the basic spheronization process which involves extrusion to form rods followed by spheronization to round the rods into spheres. It also outlines important machine parameters that influence the process like disc speed and pattern, as well as product parameters related to granule rheology.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
Documentation of technology Transfer .pptxParthRana47
This document outlines the various protocols and reports required for technology transfer between pharmaceutical companies. It discusses confidentiality agreements, licensing, research and development reports, technology transfer plans, process validation protocols, equipment and facility qualification protocols, cleaning validation protocols, and analytical methods transfer protocols. The goal of technology transfer is to ensure that manufacturing capabilities, methods, and intellectual property are effectively transferred between parties in a controlled and documented manner.
SUPAC, BACPAC, Post Marketing SurveillanceMANIKANDAN V
This document discusses various guidelines related to product development and technology transfer in the pharmaceutical industry. It covers SUPAC, BACPAC, and post-marketing surveillance. SUPAC provides guidance for scale-up and post-approval changes, categorizing changes into different levels based on their potential impact. BACPAC guidance addresses post-approval changes for bulk active pharmaceutical ingredients. Post-marketing surveillance involves monitoring adverse drug events after approval to ensure ongoing safety and effectiveness.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
This document provides an overview of spheronization as a process for producing spherical pharmaceutical granules. It defines spheronization and discusses the key advantages such as improved flow properties and uniform packing. The document describes the basic spheronization process which involves extrusion to form rods followed by spheronization to round the rods into spheres. It also outlines important machine parameters that influence the process like disc speed and pattern, as well as product parameters related to granule rheology.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
This document discusses batch manufacturing records (BMRs), which are necessary quality and GMP documentation used to trace the complete manufacturing cycle of a batch or lot of a product. A BMR contains information about the batch including the batch number, size, composition, manufacturing record, weight of drug, shelf life, and storage conditions. It also includes general manufacturing instructions, a cleaning record of equipment used, a bill of materials listing raw materials, step-by-step manufacturing process details, yield calculations, a list of abbreviations, and a history of changes made to the document. A good BMR format contains all of this essential information.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
Documentation is an essential part of good manufacturing practices in the pharmaceutical industry. Key aspects of documentation include master production records, batch records, material identification systems, laboratory records, distribution records, and complaint files. Documentation provides a complete history of each batch and helps ensure quality, traceability, and compliance with specifications and procedures. It also enables investigation of any issues that may arise.
The document discusses Batch Manufacturing Records (BMR) and Master Formula Records (MFR) for pharmaceutical manufacturing. A BMR documents each batch production run and includes the batch number, materials used, production steps, yields, and test results. An MFR is the master document that provides the standard procedure for a product and is referenced when creating individual BMRs. It includes the product name, ingredients, batch size, packaging details, and authorization. Proper documentation with BMRs and MFRs is necessary for quality control and batch traceability in pharmaceutical manufacturing.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
This document provides an overview of pharmaceutical quality management. It discusses topics like total quality management (TQM), six sigma, and quality management principles. TQM focuses on customer satisfaction and continuous process improvement. It has six basic concepts and six "C's". Six sigma uses statistical methods like DMAIC and DMADV to reduce defects and variability in processes. The document also outlines fundamentals of quality management, including quality planning, assurance, control and improvement to ensure consistency. Key quality gurus who advanced these concepts are also mentioned.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
Batch packaging record for sterile water for injection Ritika Patel
This document provides a template for a batch packaging record for sterile water for injection. It includes sections for documentation, packaging instructions, components of a batch packaging record, and a formatted example for sterile water for injection. The format example includes sections for packaging operation details, in-process checks, packaging description, labeling and packaging material details, packaging operation records, total quantity packed, and sign-offs. The purpose is to document the packaging process and ensure quality.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
Pharmaceutical packaging serves several important functions:
1) It protects drugs from external environmental factors like light, moisture, and contamination.
2) Packaging identifies drug products, provides instructions for proper use, and ensures safety and efficacy.
3) Packaging types include bottles, blister packs, vials, and other containers/closures that are evaluated through testing to ensure sterility, integrity, and that they do not interact with drug contents.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
The document defines a master formula record as specifying starting materials, quantities, packaging materials, and processing instructions to produce a finished product batch. It outlines the requirements for a master formula record including: (1) product name and reference code, composition, strength, and batch size; (2) processing location and equipment; (3) starting materials and quantities; (4) expected final yield and intermediate yields; and (5) detailed processing, storage, and packaging instructions. International guidelines from WHO, EU, PIC, Canada, and USA provide further requirements for master formula record contents.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
This document discusses batch manufacturing records (BMRs), which are necessary quality and GMP documentation used to trace the complete manufacturing cycle of a batch or lot of a product. A BMR contains information about the batch including the batch number, size, composition, manufacturing record, weight of drug, shelf life, and storage conditions. It also includes general manufacturing instructions, a cleaning record of equipment used, a bill of materials listing raw materials, step-by-step manufacturing process details, yield calculations, a list of abbreviations, and a history of changes made to the document. A good BMR format contains all of this essential information.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
Documentation is an essential part of good manufacturing practices in the pharmaceutical industry. Key aspects of documentation include master production records, batch records, material identification systems, laboratory records, distribution records, and complaint files. Documentation provides a complete history of each batch and helps ensure quality, traceability, and compliance with specifications and procedures. It also enables investigation of any issues that may arise.
The document discusses Batch Manufacturing Records (BMR) and Master Formula Records (MFR) for pharmaceutical manufacturing. A BMR documents each batch production run and includes the batch number, materials used, production steps, yields, and test results. An MFR is the master document that provides the standard procedure for a product and is referenced when creating individual BMRs. It includes the product name, ingredients, batch size, packaging details, and authorization. Proper documentation with BMRs and MFRs is necessary for quality control and batch traceability in pharmaceutical manufacturing.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
This document provides an overview of pharmaceutical quality management. It discusses topics like total quality management (TQM), six sigma, and quality management principles. TQM focuses on customer satisfaction and continuous process improvement. It has six basic concepts and six "C's". Six sigma uses statistical methods like DMAIC and DMADV to reduce defects and variability in processes. The document also outlines fundamentals of quality management, including quality planning, assurance, control and improvement to ensure consistency. Key quality gurus who advanced these concepts are also mentioned.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
Batch packaging record for sterile water for injection Ritika Patel
This document provides a template for a batch packaging record for sterile water for injection. It includes sections for documentation, packaging instructions, components of a batch packaging record, and a formatted example for sterile water for injection. The format example includes sections for packaging operation details, in-process checks, packaging description, labeling and packaging material details, packaging operation records, total quantity packed, and sign-offs. The purpose is to document the packaging process and ensure quality.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
Pharmaceutical packaging serves several important functions:
1) It protects drugs from external environmental factors like light, moisture, and contamination.
2) Packaging identifies drug products, provides instructions for proper use, and ensures safety and efficacy.
3) Packaging types include bottles, blister packs, vials, and other containers/closures that are evaluated through testing to ensure sterility, integrity, and that they do not interact with drug contents.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
The document defines a master formula record as specifying starting materials, quantities, packaging materials, and processing instructions to produce a finished product batch. It outlines the requirements for a master formula record including: (1) product name and reference code, composition, strength, and batch size; (2) processing location and equipment; (3) starting materials and quantities; (4) expected final yield and intermediate yields; and (5) detailed processing, storage, and packaging instructions. International guidelines from WHO, EU, PIC, Canada, and USA provide further requirements for master formula record contents.
This document discusses risk-based models for assessing facilities and operations for sterile manufacturing. It presents a risk calculator and risk assessment matrix for determining risk priority numbers. The risk models evaluate factors for aseptic sterile operations and terminally sterilized products, such as raw materials, personnel, facilities, cleaning processes, and filling/sterilization operations. Key parameters include process understanding, quality control, personnel training, environmental monitoring, and validation of sterilization processes. The goal is to use a risk-based approach to identify and control critical quality parameters.
The document summarizes findings from a project testing batch processing performance using J2EE. It discusses considerations for batch frameworks, infrastructure, caching, logging, design challenges, and whether to use batch processing. It also outlines the design of the batch process used, including leveraging raw JDBC, Oracle caching, and tools for performance monitoring.
This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the FDA for drug approval. It describes the goals and contents of an NDA, including clinical trial data and manufacturing information, as well as the multi-step review process. For ANDAs, the goals are to reduce drug costs and development time by allowing generics if they are equivalent to branded drugs. ANDAs must demonstrate bioequivalence but do not require new clinical trials. The document provides details on patent certification and approval processes for both NDA and ANDA submissions.
This document discusses microbiology and sterility in sterile manufacturing. It provides background on microorganisms including bacteria, fungi, and viruses. It describes Gram staining and environmental factors that influence microbial growth like nutrients, temperature, and humidity. The document outlines compendial microorganisms used for sterility testing. It defines sterility as a probability of less than one non-sterile unit per million based on exponential microbial death from processing. Statistical capability and achieving a sterility assurance level of 10-6 are also covered.
Advent Net Manage Engine Service Desk Plus Help Admin Guideguestf80501
The document provides an overview of the key modules and functionality of ManageEngine ServiceDesk Plus. It describes the main modules for managing requests, problems, changes, assets, purchases, and contracts. The request module functions as the help desk where technicians resolve user issues. Problem management seeks to identify the root cause of incidents to prevent recurrences. Change management ensures standardized processes for handling changes. Additional modules allow for asset, purchase, and contract management.
1) The document discusses that while HPLC is commonly used for dissolution testing, UV/Vis spectrophotometry can also be used if validated for the purpose.
2) It notes that dissolution testing is intended to evaluate the quantitative release pattern of drug products, not stability-indicating properties.
3) The document concludes that if UV/Vis spectrophotometry can accomplish the objectives of dissolution testing and its use is justified and validated, it should not be discouraged simply due to common use of HPLC, which increases costs and testing time without clear benefits in some cases.
Electronic Batch Manufacturing records and MES in PharmaceuticalNilay Sharma
The document discusses the adoption of electronic batch manufacturing records (eBMR) and manufacturing execution systems (MES) in the pharmaceutical industry. It notes that pharmaceutical companies are under pressure to minimize human errors and ensure regulatory compliance, driving adoption of technology solutions. While ERP systems tracked workflows and materials, they lacked control over manufacturing processes. eBMR and MES help address this by enabling equipment to communicate process parameters and measurements digitally in real-time rather than relying on manual recording. This increases accuracy, productivity and ensures compliance. The document provides an overview of Base E12 MES and eBMR software.
This document discusses the design, trust, and control of sterile manufacturing. It begins with opening questions about which dosage form approaches vital organs fastest (injection), which manufacturing area requires the highest control of particles and microorganisms (injection manufacturing), and which defect is most difficult to detect (contamination). The document then provides an overview of inherent challenges in sterile manufacturing and notes that injectables are easy to formulate but difficult to manufacture due to the need for strict control of contamination. It emphasizes that contamination in injectables can lead to serious health consequences since injections take effect rapidly and potential issues may not be reversible. The document stresses that particles and microbial contamination present a continuous challenge in sterile manufacturing.
This document discusses sterile manufacturing and the invisible issues related to particulate matter in sterile injectable pharmaceutical products. It focuses on the risks of viable and non-viable particles, identifying sources of particulate contamination, and strategies for dynamic contamination control. Proper facility design, material and personnel flow, environmental monitoring and validation are needed for aseptic manufacturing to minimize particulate matter that can cause health risks like infection, embolism or allergic reaction when injected.
This document provides guidance on cleanroom classifications and air quality standards for the manufacture of sterile products. It outlines four grades (A, B, C, D) for clean areas based on required airborne particulate and microbial limits. Grade A is for high-risk operations like filling and requires laminar airflow. Grades B, C, D are for less critical processes. Air quality standards are provided for "at rest" and "in operation" states. Monitoring of clean areas during production is recommended to control particulate and microbial levels.
This document provides information on the various registrations and licenses required for starting an export business in India. It discusses obtaining an Importer-Exporter Code (IEC) number from the Directorate General of Foreign Trade, which is mandatory for any import or export activity. It also summarizes the process for registering with other authorities such as sales tax, central excise, Export Credit Guarantee Corporation for export credit insurance, and membership in export promotion councils. The document outlines the key requirements and documents needed for applying for an IEC number and highlights some exemptions. It stresses the importance of checking that export items do not fall under the Negative List requiring licenses or prohibitions.
The document discusses several economic, political, and social reforms and policies implemented during President Gloria Macapagal Arroyo's administration from 2001 to 2010. Specifically, it mentions the restructuring of the value-added tax system, measures to boost gross national product and domestic product, expansion of the tax base through an expanded value-added tax, and coordination of fiscal policies that strengthened the Philippine peso and stabilized the economy. In the political sphere, it discusses an amnesty proclamation for rebel groups and abolition of the death penalty. Socially, it highlights the growth of call centers that provided employment.
Benigno Simeon Aquino III is the 15th and current President of the Philippines. He is the son of former Senator Benigno Aquino Jr. and former President Corazon Aquino, both icons of democracy in the Philippines. Aquino attended Ateneo de Manila University and worked in the private sector before entering public service. He served as a Congressman and Senator, advocating for policies to uphold accountability and address people's concerns. In 2010, amid calls for change, Aquino ran for President on an anti-corruption platform, winning the election. He aims to transform the government from one that is self-serving to one that works for the welfare of the nation.
President Benigno Simeon "Noynoy" Aquino III is the current president of The republic of the Philippines as of 2010 and in this presentation, you will come to see his accomplishments in 3 years, that makes it 2010-2013
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
The document provides information on the development and importance of pharmaceutical documentation. It discusses different types of documents including commitment documents like New Drug Applications and Drug Master Files, directive documents like specifications and standard operating procedures, and record documents like batch production records and protocols. The document also outlines general requirements and guidelines for designing documentation systems in accordance with cGMP.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
documentation in pharmaceutical industry.pdfSoumiliPaul1
Documentation in the pharmaceutical industry plays a crucial role in maintaining quality, compliance, and safety standards. It encompasses standard operating procedures, quality audits, review of quality documentation, and generation of various reports and distribution records. Master formula records provide complete descriptions of all aspects of manufacturing, packing, and quality control. Quality audits verify that quality activities comply with plans and that arrangements are suitable to achieve objectives. Documentation includes internal audits by a company's employees and external audits by separate organizations.
The document discusses specifications and submission of documents for pharmaceutical products. It provides definitions and types of specifications for active materials, packing materials, intermediates, bulk, and finished products. It also discusses test procedures, protocols, reports, distribution records, electronic data handling, concepts of controlled vs uncontrolled documents, and submissions to regulators like DMFs, CTD, and eCTD. Specifications include parameters and acceptance limits. Test procedures must be validated and may reference official substances. Protocols, reports, and distribution records are important documentation for manufacturing and quality control. Electronic data handling can streamline documentation but has challenges around costs, connectivity, security, and validation.
This document discusses the validation of raw materials used in pharmaceutical manufacturing. It defines validation as demonstrating through documented evidence that a process will consistently produce a product meeting predetermined specifications. The document outlines a 7 step process for validating raw materials: 1) List all raw materials needed, 2) Identify at least two suppliers for each material, 3) Qualify new suppliers by inspecting facilities, 4) Obtain supplier certificates of analysis and samples, 5) Establish specifications for each material, 6) Establish test procedures, 7) Establish sampling procedures. The validation process confirms raw materials meet specifications and ensures uniform, high quality batches.
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
The document discusses documentation requirements in the pharmaceutical industry. It defines documentation and explains that documentation is an integral part of good manufacturing practices (GMP). It describes the objectives of documentation such as defining specifications and procedures. It provides details about types of documentation required by GMP such as master formula records, batch manufacturing records, distribution records, specifications, and quality auditing. The document emphasizes that comprehensive documentation is necessary to ensure product quality and traceability in the pharmaceutical industry.
Documentation in pharmaceutical industryPooja Harkal
It's all about the topic of documentation in pharmaceutical industry. In this the specifications of pharmaceutical quality assurance plays the main role so that it's mainly effective for the people who is in the stream of pharmaceutical quality assurance.
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
Documentation is a crucial part of the quality assurance system and is needed in every aspect of pharmaceutical manufacturing. Important documentation with respect to final product release in pharmaceutical industry is explained in brief.
This document discusses documentation practices in the pharmaceutical industry. It begins by defining documentation and explaining its importance. Documentation provides written records of processes, ensures regulatory compliance, and allows for traceability and investigation. The document then discusses types of documents used like specifications, standard operating procedures, batch records, and quality control records. It explains the purpose and requirements for key documents like master formula records, batch production records, and material records. Overall, the document emphasizes that documentation is essential for quality assurance and compliance in the pharmaceutical industry.
Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
Unit 4 Document maintenance in Pharmaceutical Industry.pptxAshwiniBhoir2
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2. OBJECTIVE
The objective of this presentation to emphasis
the importance of documentation
for
industries and describe
the protocols
regarding this also their management.
3. DOCUMENT & DOCUMENTATION
•Document is written statement of proof
The document can
Assure that quality standards are consistently met.
Communicate these standards all who interact with
project.
A Document System is an interacting set of documents,
each with a defined purpose and consistent document.
4. TYPES OF DOCUMENTS
Commitment Document
Relationship between industry and the regulatory
authorities.
Directive document
Relationship between management and employee
Record document
Relationship between the employee and the work
they perform.
5. DOCUMENTATION is a process that involve the systematic
interaction of people, events and document to create the records
of the organisation/corporate
Documentation is the key to GMP compliance and ensures
traceability of all development, manufacturing, and testing
activities. Documentation provides the route for auditors to
assess the overall quality of operations within a company and the
final product.
6. THE 10 GOLDEN RULES OF GMP
1 Get the facility design right from the start
2 Validate processes
3 Write good procedures and follow them
4 Identify who does what
5 Keep good records
6 Train and develop staff
7 Practice good hygiene
8 Maintain facilities and equipment
9 Build quality into the whole product lifecycle
10 Perform regular audits
7. LIST OF THE MOST COMMON TYPES OF
DOCUMENTS USED FOR GMP
DOCUMENT
DESCRIPTION
Quality
manual
A global company document that describes, in paragraph form, the
regulations and/or parts of the regulations that the company is
Required to follow
Policies
Documents that describe in general terms, and not with step-by-step
instructions, how specific GMP aspects (such as security,
documentation, health, and responsibilities) will be implemented.
(SOPs)
Step-by-step instructions for performing operational tasks or
activities.
Batch Records
These documents are typically used and completed by the
manufacturing department. Batch records provide step-by-step
instructions for production-related tasks and activities, besides
including areas on the batch record itself for documenting such
tasks.
8. Test methods
These documents are typically used and completed by the quality
control (QC) department. Test methods provide step-by-step
instructions for testing supplies, materials, products, and other
production-related tasks and activities, e.g., environmental
monitoring of the GMP facility. Test methods typically contain forms
that have to be filled in at the end of the procedure; this is for
documenting the testing and the results of the testing.
Specifications:
Documents that list the requirements that a supply, material, or
product must meet before being released for use or sale. The QC
department will compare their test results to specifications to
determine if they pass the test.
Logbooks
Bound collection of forms used to document activities. Typically,
logbooks are used for documenting the operation, maintenance, and
calibration of a piece of equipment. Logbooks are also used to record
critical activities, e.g., monitoring of clean rooms, solution
preparation, recording of deviation, change controls and its
corrective action assignment.
9. OBJECTIVE & IMPORTENCE OF
DOCUMENTATION
OBJECTIVE• Define the manufacturer’s information system and control
strategies clear.
•Minimises the risk of misinterpretation and errors.
•Confirmation of task performed.
•Tracing the batch history of any product
IMPORTENCE• Good documentation is an essential part of quality assurance
system and must be as requirement of GMP.
•Define the specifications of each product
•Ensure the quality
• Ensures that the responsible authorities, have knowledge of
the work carried out.
11. INCLUSIONS OF DOCUMENTATION
Revised schedule M has the following elements which are
related to documentation:---- Records
Labels
Specifications And Testing Procedures
Master Formulae
Packaging Instructions
Batch Production and Control records (BPCR) / Batch
Manufacturing Records
Batch Packaging Records (BPR)
Standard Operating Procedures (SOPs)
11
12. Introduction
In pharma industry, Labels are used for identification and/or status of
container, equipment and premises.
Labels should be unambiguous and in format approved by the company.
Sometimes colored labels are used to indicate status. For Example, colored
labels for starting materials according to their status:
Quarantine
Yellow
Approved
Green
Rejected
Red
12
13. Label of finished product
• Name of product
• Ingredients
• Net Content
• Batch number
• Expiry date
• Storage condition
• Information about manufacturing company (Lice. No. and Address)
13
14. Label of reference standard
• Name of material
• Potency
• Date of preparation
• Batch number
• Shelf-life
• Storage condition
14
15. • Introduction
• Specifications for Raw Materials
• Specifications for Finished Product
• Specifications for Packaging Materials
• Testing Procedures
HNSIPER
15
16. INTRODUCTION
It is a list of detailed requirements with which product/material
used or procedure followed during manufacture need to
conform.
They serve as basis for quality evaluation.
Specifications should be available for :
• Raw Materials
• Finished Products
• Packaging Materials
First twos can be referred from their individual monographs
from pharmacopoeia.
If standard data is not available in pharmacopoeia, then
manufacturer can write specification himself.
Specifications for packaging materials such as plastic or glass
containers and closers etcetera, are not given by any
monograph. However certain requirements have been laid down
for them in appendix-11 of I.P.
16
17. Bureau of Indian Standards (BIS) has prepared
specifications for various packaging materials.
These specifications are given prefix as “IS”, means
‘Indian Standard’.
There are 18210 numbers of Indian Standards.*
Certain specifications amongst them are specifically
prepared for pharmaceutical industry, while the rest
are general specifications.
17
18. SPECIFICATIONS FOR RAW MATERIALS
Generic and chemical name of material
Trade name or product code established any manufacturer
Description
Name of pharmacopoeia or any other recognized book of
standards in which monograph appears or INN
(International Non-proprietary Name).
Approved supplier
Frequency of testing of stored material
Special precautions to be taken during storage including
safety aspects
Date of Issue of specifications
18
19. SPECIFICATIONS FOR FINISHED PRODUCT
Generic name of product
Trade name
Dosage form and Strength
Description (Color, State, Dimension, Taste)
Physical properties ( Weight/Volume (with limit), pH,Viscosity,
Density, Hardness, Friability, Disintegration time, Dissolution Time
etcetera)
Name of Pharmacopoeia as a reference
Date of Expiry
Precautions during storage including safety aspects
Date of issue of specification
19
20. SPECIFICATIONS FOR PACKAGING MATERIALS
Below mentioned Indian standards may referred,
while preparing specifications for packaging materials:
Number of IS
Specification for
IS 7803
Plastic Containers
IS 3692
Rubber Closures
IS 1776
Folding Box Board
IS 2771
Corrugated Box
IS 3101
Collapsible Tubes
IS 7852
Eye Ointment Tubes
IS 10133
Glass Bottles
IS 8970
Paper Aluminum Foil
IS 8393
Pilfer Proof Closures
IS 1984
Glass Vials
20
21. TESTING PROCEDURES
These are nothing but the procedures for testing raw
materials, intermediated and finished products.
These procedures are basically based on Pharmaceutics
and Analytical techniques.
While preparing these procedures Various pharmacopoeia
(like IP, BP, JP, EP, USP etc) and other recognized books of
standards like drug and cosmetics rules, USNF, other
authoritative books on analysis of drugs.
21
22. FORMAT FOR STANDARD TESTING PROCEDURE
Name :
Pages:
Code No. :
Shelf Life :
Status :
Effective Date :
STP No. :
Review Period :
Prepared By
Checked By
Approved By
Signature
Date
22
24. Definition
Master formulae also can be said and written as ‘Master
Formula Record’, ‘Manufacturing Formula’, ‘Master
Production and Control Record’ (MPCR) etcetera.
It is defined as “An approved master document that describes the full
process of manufacturing for the batch of specific
product.”
It includes all the materials used in any batch
manufacturing and step by step process of manufacturing.
24
25. PREPARATION OF MATER FORMULAE
Master formulae can be prepared by competent
technical staff.
It should be reviewed by the heads of production,
quality control department and research &
development.
25
26. Description
Name and Strength of the product along with dosage form
MFR No.
A complete list of all ingredients with their quantity
Description of Containers, Closures and Packaging materials to
be used
Description of all Vessels and Equipments used in the process
Processing and Packaging Instructions
IPQCs to be exercised during processing and packaging
Precautions to be taken during manufacture and storage of semifinished product including any special storage conditions
Reference
26
29. Definition
Batch Processing Record can also be said as Batch
Manufacturing Record (BPCR) .
It is defined as –
“The Batch Manufacturing Record (BPCR) is the
necessary quality and GMP documentation for
tracing the complete cycle of manufacture of a
batch or lot.”
29
30. CONTENTS OF BPCR
The name and batch number of the product
Dates and times of commencement, of significant intermediate stages and
of completion of production
Identification (initials) of the operator(s) who performed each significant
step of the process and, where appropriate, the name of any person who
checked these operations
Quantities of each starting material actually weighed
A record of the in-process controls and the initials of the person(s)
carrying them
The product yield obtained at different and pertinent stages of
manufacture
Notes on special problems including details, with signed authorization for
any deviation from the Manufacturing Formula and Processing
Instructions
Approval by the person responsible for the processing operations.
30
32. INTRODUCTION
In fact, BPR is a part of BPCR.
These records are based on packaging instructions.
One important operation that should be carried out before
packaging operation is line purging (clearance).
32
33. CONTENTS OF BPR
Name, Batch number and Qty. of bulk finished product to be
packed
Theoretical and Actual Yield and Reconciliation
The date and time of the packaging operation
The name of responsible person and his initials
Details of packaging instructions like equipments and
packaging lines used
Qty. along with identification of different printed packaging
materials issued, used, destroyed and/or returned to store
and reconciliation
In any case of problems, if any deviation made, written
authorization for the same
33
35. INTRODUCTION
Site Master File is a document, which gives a complete
information regarding a site of pharmaceutical plant.
This document generally should not be very massive,
like running into more than 100 pages.
M.H.R.A. (Medicines and Healthcare products
Regulatory Agency), a government agency of U.K., has
given certain guidelines for length of the format for it.
35
36. INCLUSIONS OF SMF
The Information about Company
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Contract manufacture and analysis
Distribution, Complaints and Product Recalls
Regulatory inspections and self-inspections
Details of Annual Product Review
Change Control System
Technical Quality Agreement for Contract Manufacturing
(Technical Agreement, Quality Agreement)
36
38. Sub-part A-General Provision
Sub-part B•Responsibilities of QC unit
•Available facility of QC unit
•List of critical instruments
•Quality control manual
•Training manual
•Attendance records of trainee
•Training evaluation records
•List of employees
•Organogrammes
•Job description
•SOP on appropriate clothing and protective apparels.
•SOP on practice of good sanitation and health habits.
•SOP on entry procedures to factory and various department.
•SOP on pre & post employment medical check-up of employees.
•Records of consultants.
39. Sub-part C
•Statement of formulation & their volumes
•Plans of the facility
•Area specifications of building, facilities.
•SOP on buying & facility cleaning and sanitation
•SOP on building & facility maintenance
•SOP on maintain of environmental condition
•SOP on cleaning & disinfection of aseptic areas & equipments.
•Statement of lighting requirements in the facility
•HVAC system
•Plumbing diagram
•SOP on sewage and refuse handling
•Diagram of washing and toilet facilities.
•SOP on pests, rodent, birds, insects and vermin control
•Job description of sanitary inspector
40. Subpart D•Equipment description list
•Equipment M.O.C. List
•SOP on cleaning, operation & maintenance of each and
every identified equipment.
•SOP on records of calibration
•List of filters for injectables.
41. Subpart –E
•SOP on receipt and storage of R.M./P.M.
•List of RM/PM with their storage
•SOP on sampling of RM/PM
•SOP on tasting and approval or rejection of materials
•SOP on re-testing of approve material.
•SOP on handling of rejected materials.
•List of primary packaging materials and their composition.
•SOP on testing of closure system.
•SOP on cleaning, sterilization and depyrigenating the container and
closures.
•SOP and record on vendor certification.
42. Sub-Part-F
•SOP on change control procedure
•SOP on dispensing of batch materials.
•List of critical phases of operation where yield should be
checked.
•Equipment identification record
•SOP on sampling and testing of in process materials.
•SOP on time limitation on production.
•SOP on validation of sterilization process.
•SOP on reprocessing of materials
43. Sub-Part G
•SOP on receipt identification, storage, handling, sampling, examination
testing of labelling & packaging materials.
•SOP on issue of printed packaging materials
•SOP on IPQC during packaging and labelling operation
•SOP on expiration dating.
Sub-Part-H
•SOP on quarantine of finished products before release by QC.
•SOP on storage of finished products under appropriate condition of
temperature, humidity and light.
•SOP on distribution of finished products.
44. Sub-part I•Written specification
•SOP on calibration
•SOP on validation
•SOP on stability testing
•SOP on special testing requirements
•SOP on reserve samples
•Records of laboratory animals
•SOP on penicillin contamination
45. Sub-part J
•Equipment cleaning, use and maintenance log
•Material receiving record
•Results of examination and testing of materials
•Material inventory record
•Records of disposition of rejected materials
•Master production and control record.
•Batch production and control record
•Production record review.
•QC laboratory record should have all the
documents listed in 211.194 distribution record.
•SOP on complaints and their reports/records.
46. Sub-part K
•SOP on handling of returned product.
•SOP n handling of salvaging.
48. USE OF MAINTENANCE RECORDS
The use of maintenance records is particularly important in
a factory setting, where a large number of expensive
machines are used daily.
These records can help make sure that any appropriate
equipment maintenance or plant maintenance has been
completed so that plant operations will run smoothly.
For instance, a maintenance log detailing any repairs or
service upkeep may be kept on a factory machine. This log
can help avoid accidents or plant shut-downs resulting
from defective equipment
48
49. MAINTENANCE RECORD MANAGEMENT
Maintenance record management can be important for a
number of reasons: Good records help department managers and employees
ensure that a piece of equipment is performing in line with
any manufacturer warranties.
Maintenance records also help companies track when a
piece of equipment needs to undergo preventive
maintenance. If a company gets sued in relation to a faulty
piece of equipment, maintenance records can be essential
in supporting the company's case.
49
51. RECORD KEEPING
Records provide history of a batch
1. Name and address of supplier of each drug product with date
2. Name and address of purchaser of each drug product with
date
3. Supplier or purchaser licensed
4. Retention of order forms, copy of delivery notes, stores
receipt, and issue vouchers ,and book of records (controlled
drugs book/prescription drugs book) on the premises as
provided for in the drug laws.
5. Accuracy of records kept.
51
52. PURPOSE AND PRINCIPLE OF RECORDS
Scientific
Regulatory requirement
Business purpose
Maintenance of Records is the essential part of quality
assurance system
Records must be free from errors
52
53. RETENTION OF RECORDS
Records should be kept in such a way that activities
concerning the production and quality control of active
pharmaceutical ingredients are traceable.
Records should be retained for at least one year after the
expiry of the finished product or for a specified period if
there is no expiry date.
53
54. RECORDS MAINTENANCE
The functions of records maintenance include the following
essential components:
Organizing and filing records
Identifying which records to retain, and for how long
54
55. CONCLUSION
Documentation is necessary in pharmaceutical industry
Documentation is a key area for companies in the
pharmaceutical industry. The United States Food and Drug
Administration (FDA)-the governmental agency, that is
responsible for overseeing the industry, requires extensive
documentation for every manufacturing and packaging lot of
all pharmaceutical products.
The FDA mandates documentation for the sake of
accountability and traceability.
This practice is to ensure safe and effective pharmaceutical
products.