WHO guided Model Certificate of Analysis (COA) for pharmaceuticals/Chemical industries/API Manufacturers to submit dosier for export regulatory market or in-house release purposes.
Center for Biologics Evaluation and ResearchRajeswariS12
The Center for Biologics Evaluation and Research (CBER) is one of six main centers of the US Food and Drug Administration that regulates biological products intended for human use. CBER is responsible for ensuring the safety, purity, potency, and effectiveness of biologics such as vaccines, blood products, cell and gene therapies. It oversees the testing, licensing, and post-market monitoring of these products. CBER staff review clinical trial data submitted in Biologics License Applications to determine if a biologic is safe and effective before approval.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
This document discusses specifications and certificates of analysis (COA), which are important documentation in the pharmaceutical industry. It provides details on the purpose, scope and required contents of specifications for raw materials, packaging materials, in-process materials, finished products, and preparation of containers. It also covers the purpose, contents and examples of COAs, which report analytical results for batches to ensure they meet specifications. COAs should include batch information, test acceptance criteria, results, and approval. Electronic COAs are also commonly used if appropriate controls are in place for the computer system generating them.
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
The document discusses the inspection of drug distribution channels. It covers the qualifications and attributes of drug inspectors, which include good knowledge of pharmacy laws and regulations, as well as integrity and communication skills. It also describes the organizational aspects of inspectors and different methods of inspection, such as comprehensive, concise, follow-up, and investigative inspections. The objectives of inspecting establishments are to ensure protection of patients, high ethical standards, and compliance with regulations. Special categories of drugs may require a modified inspection procedure.
This document provides an overview of the regulatory guidelines for developing and marketing biologics in Europe. It discusses the EU guidelines for non-clinical and clinical studies from trials through approval. For non-clinical studies, the CHMP has adopted ICH S6 and its addendum which provides guidance on species selection, study design, immunogenicity, reproductive/developmental toxicity, and carcinogenicity assessments. Clinical studies must comply with the Clinical Trials Directive and guidelines on GCP, informed consent, data handling and confidentiality. The marketing authorization application process is similar to other products but requires additional information specific to biologics manufacturing.
Center for Biologics Evaluation and ResearchRajeswariS12
The Center for Biologics Evaluation and Research (CBER) is one of six main centers of the US Food and Drug Administration that regulates biological products intended for human use. CBER is responsible for ensuring the safety, purity, potency, and effectiveness of biologics such as vaccines, blood products, cell and gene therapies. It oversees the testing, licensing, and post-market monitoring of these products. CBER staff review clinical trial data submitted in Biologics License Applications to determine if a biologic is safe and effective before approval.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
This document discusses specifications and certificates of analysis (COA), which are important documentation in the pharmaceutical industry. It provides details on the purpose, scope and required contents of specifications for raw materials, packaging materials, in-process materials, finished products, and preparation of containers. It also covers the purpose, contents and examples of COAs, which report analytical results for batches to ensure they meet specifications. COAs should include batch information, test acceptance criteria, results, and approval. Electronic COAs are also commonly used if appropriate controls are in place for the computer system generating them.
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
The document discusses the inspection of drug distribution channels. It covers the qualifications and attributes of drug inspectors, which include good knowledge of pharmacy laws and regulations, as well as integrity and communication skills. It also describes the organizational aspects of inspectors and different methods of inspection, such as comprehensive, concise, follow-up, and investigative inspections. The objectives of inspecting establishments are to ensure protection of patients, high ethical standards, and compliance with regulations. Special categories of drugs may require a modified inspection procedure.
This document provides an overview of the regulatory guidelines for developing and marketing biologics in Europe. It discusses the EU guidelines for non-clinical and clinical studies from trials through approval. For non-clinical studies, the CHMP has adopted ICH S6 and its addendum which provides guidance on species selection, study design, immunogenicity, reproductive/developmental toxicity, and carcinogenicity assessments. Clinical studies must comply with the Clinical Trials Directive and guidelines on GCP, informed consent, data handling and confidentiality. The marketing authorization application process is similar to other products but requires additional information specific to biologics manufacturing.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
This document summarizes a presentation on future compliance requirements related to medical devices. It discusses changes coming in how medical devices are named (GMDN), tracked (UDI), and have data captured (AIDC/GS1 coding). The Global Medical Device Nomenclature (GMDN) will standardize device names. Unique Device Identification (UDI) will assign each device a unique identifier tracked in a public database. Automatic identification like GS1 coding will help interface equipment and data. Hospitals should prepare by understanding these changes to integrate new identification standards.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
National Sanitation Foundation(NSF) CertificationSanthiNori1
National Sanitation Foundation (NSF) is an independent organization that develops standards and certifies products to ensure public health and safety. NSF has developed over 80 public health standards, including standards for dietary supplements. The certification process for dietary supplements involves label claim review, toxicology review, contaminant testing, facility audits, and ongoing monitoring. NSF standards specify requirements for dietary supplement identity, quantity, and limits on contaminants like heavy metals and microbiologicals. The standards help ensure supplements are accurately labeled and free of harmful contaminants.
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
This document summarizes a presentation about differences between US and Indian GMP standards. It was compiled by a nonprofit organization called "Drug Regulations" that provides online pharmaceutical resources. The organization's website, www.drugregulations.org, can be visited for the latest information on pharmaceutical regulations from around the world.
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.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
The document discusses various documentation practices that are important in the pharmaceutical industry. It covers documentation requirements for raw materials, packaging materials, production records, quality control records, and other key areas. Maintaining proper documentation is essential for regulatory compliance, process validation, batch traceability, and ensuring product quality.
Drugs and Cosmetics Act 1940 And Their Under 1945Tushar Morankar
The document outlines the record keeping requirements for drugs and cosmetics manufacturers under Schedule U of the Drugs and Cosmetics Rules, 1945 in India. It details the information that must be included in manufacturing records for raw materials, analytical testing records, and batch records for both non-parenteral and parenteral drug preparations. This includes the product name, batch details, raw material quantities, quality control checks, analytical reports, and signatures of those responsible for production and quality approval. Record keeping for raw material receipts and usage is also specified.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
This document summarizes a presentation on future compliance requirements related to medical devices. It discusses changes coming in how medical devices are named (GMDN), tracked (UDI), and have data captured (AIDC/GS1 coding). The Global Medical Device Nomenclature (GMDN) will standardize device names. Unique Device Identification (UDI) will assign each device a unique identifier tracked in a public database. Automatic identification like GS1 coding will help interface equipment and data. Hospitals should prepare by understanding these changes to integrate new identification standards.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
National Sanitation Foundation(NSF) CertificationSanthiNori1
National Sanitation Foundation (NSF) is an independent organization that develops standards and certifies products to ensure public health and safety. NSF has developed over 80 public health standards, including standards for dietary supplements. The certification process for dietary supplements involves label claim review, toxicology review, contaminant testing, facility audits, and ongoing monitoring. NSF standards specify requirements for dietary supplement identity, quantity, and limits on contaminants like heavy metals and microbiologicals. The standards help ensure supplements are accurately labeled and free of harmful contaminants.
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
This document summarizes a presentation about differences between US and Indian GMP standards. It was compiled by a nonprofit organization called "Drug Regulations" that provides online pharmaceutical resources. The organization's website, www.drugregulations.org, can be visited for the latest information on pharmaceutical regulations from around the world.
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.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
The document discusses various documentation practices that are important in the pharmaceutical industry. It covers documentation requirements for raw materials, packaging materials, production records, quality control records, and other key areas. Maintaining proper documentation is essential for regulatory compliance, process validation, batch traceability, and ensuring product quality.
Drugs and Cosmetics Act 1940 And Their Under 1945Tushar Morankar
The document outlines the record keeping requirements for drugs and cosmetics manufacturers under Schedule U of the Drugs and Cosmetics Rules, 1945 in India. It details the information that must be included in manufacturing records for raw materials, analytical testing records, and batch records for both non-parenteral and parenteral drug preparations. This includes the product name, batch details, raw material quantities, quality control checks, analytical reports, and signatures of those responsible for production and quality approval. Record keeping for raw material receipts and usage is also specified.
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.
Good Practices in QC Lab in Pharma industriesDr. Amsavel A
The document provides definitions and guidelines for quality control laboratory management. It discusses definitions of key terms, requirements for quality control documentation and records, personnel qualifications, sample management, use of reagents and reference standards, instrument calibration, analytical methods, and data review. The document emphasizes that quality control laboratories must meet regulatory requirements and operate according to good practices and management systems to ensure the quality of pharmaceutical products.
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.
The document outlines the minimum requirements for records that must be maintained by licensed manufacturers of drugs and cosmetics according to Schedule U of the Drugs and Cosmetics Act. It details the particulars that must be recorded for manufacturing processes, raw materials, and analytical testing for various drug products including tablets/capsules, parenteral preparations, and other drugs. Records must be maintained for batch numbers, ingredients, manufacturing steps, environmental controls, quality checks, analytical results, and more. The licensing authority may require additional records as needed.
This document provides an overview of the history and development of Good Manufacturing Practices (GMP) regulations. It discusses key events that led to the establishment of GMP standards, including unsafe drug production in the early 1900s and the Thalidomide tragedy in the 1960s. The document then outlines the main GMP guidelines covering areas like personnel, facilities, equipment, sanitation, documentation, raw materials, quality assurance, and more. It traces the timeline of major GMP-related acts and amendments between 1902-1980 to strengthen drug and medical device manufacturing standards.
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.
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
The document discusses the importance of batch manufacturing records (BMRs) in pharmaceutical manufacturing. It states that BMRs should document every step of the manufacturing process for a particular batch, including equipment used, materials added, process parameters, samples taken, and test results. They help trace the complete manufacturing cycle and ensure consistency between batches. The document outlines the responsibilities of production, quality assurance, and quality control in preparing, reviewing, and approving BMRs to ensure compliance with GMP standards.
This document discusses the process of generic drug product development. It explains that a generic drug is identical to the branded reference drug in terms of active ingredients, dosage form, safety and efficacy. The document then outlines several key steps in generic drug development, including selecting a product, ensuring API availability, developing analytical methods, conducting formulation development studies, manufacturing exhibit batches, conducting bioequivalence studies, and seeking regulatory approval from agencies like the FDA. It also discusses provisions of the Hatch-Waxman Act that aim to facilitate generic drug approval while compensating branded manufacturers.
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
ICH guidelines on impurities in new drug products.pptxDivya Pushp
This document provides a summary of a presentation on ICH guidelines for impurities in new drug products. The guidelines provide guidance for registration applications on reporting and qualifying degradation products and impurities. Key points include: analytical procedures must be validated for detecting degradation products; batches used in development and commercial processes must be compared; degradation products above certain thresholds must be identified, reported, and qualified; and specifications for degradation products should be based on batches from the commercial process. The guidelines do not apply to certain product types like biologics but provide direction on identifying, analyzing, reporting, and qualifying degradation products found in new small molecule drug products.
The document discusses the WHO certification scheme for pharmaceutical products. It provides details on the history and revisions of the WHO certification scheme. It describes the types of certificates that can be issued under the scheme including certificates of pharmaceutical products, statements of licensing status, and batch certificates. It outlines the guidelines for participation in the scheme, requesting and issuing certificates, and procedures for investigating quality defects. The aim of the scheme is to help assure good manufacturing practices and quality of pharmaceutical products being exported between member states.
Types of validation & validation of specific dosage.pptxankitanakashe21
This document discusses validation of pharmaceutical dosage forms and processes. It begins with definitions of validation and different types of validation including process validation, cleaning validation, equipment validation, and analytical method validation. It then discusses specific validation procedures and parameters for various dosage forms like solid dosage forms (tablets), liquid dosage forms, and semi-solid dosage forms. A significant portion of the document focuses on validation of tablet manufacturing processes and parameters like mixing/blending, wet granulation, and control strategies. It emphasizes collecting data to demonstrate a process is capable of consistently producing quality products.
This document discusses periodic testing requirements for children's products. It explains that periodic testing must be conducted by a CPSC-accepted third party laboratory, with the required frequency depending on the manufacturer's chosen option - either annually, every 2 years if a production testing plan is established, or every 3 years if using an ISO-accredited lab for continued testing. The frequency may also need to be more than annually based on factors like variability in test results or potential for serious injury. Manufacturers must document their periodic testing plan and maintain testing records for 5 years. Component part testing by suppliers can be relied on if certain conditions are met.
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.
Batch release certificate for medical deviceMalesh M
A Batch Release Certificate is a document issued by a medical device manufacturer that provides evidence they tested a batch of devices against specifications. It certifies the analysis of raw materials and finished devices to ensure compliance with Good Manufacturing Practice standards. The certificate includes a description of test methods used, limits, and actual test results for the batch, and must be reviewed and approved by quality control personnel.
Similar to WHO Guidance on Model Certificate of Analysis (COA) (20)
The University of Tartu certified that Md Selim Reza, born December 1, 1980, completed a 52-hour continuing education program called "LC-MS Method Validation" from November 27, 2018 to February 8, 2019. The certificate was issued on February 8, 2019 and signed by the Deputy Head of the Office of Academic Affairs and the Programme Director for Continuing Education.
Md selim reza_supplement_to_completion_certificateMD. SELIM REZA
This document is a certificate summarizing Md Selim Reza's completion of a 52-hour continuing education programme on LC-MS Method Validation from November 27, 2018 to February 8, 2019. It was issued by Tiia Ristolainen, Deputy Head of the Office of Academic Affairs and Esta Pilt, Programme Director for Continuing Education. The course covered topics like selectivity, linearity, precision, trueness, accuracy, stability, detection limits, ruggedness and robustness. Upon successful completion, participants would understand key method performance parameters, be able to design validation experiments and assessments, and evaluate a method's fitness for its intended purpose based on the validation results. Md Selim Reza received an
Discovering science-science-writing certificate-of_achievement_mv2ayqeMD. SELIM REZA
Md. Selim Reza completed a two-week course called "Discovering Science: Science Writing" from the University of Leeds. The course explored how to structure narratives and convey messages using different writing formats for science writing. It also covered topics like interview techniques and using video to communicate scientific information to various audiences. The course aimed to explain different types of science writing and help students develop news articles, blog posts, or video scripts about science.
ICH 7- GMP Guidance for API-questions & answersMD. SELIM REZA
This document provides clarification on uncertainties regarding the interpretation of certain sections of the ICH Q7 guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients. It answers questions on applying GMP to manufacturing steps before and after the defined API starting material. It also addresses questions on applying GMP to steps that add substances to stabilize an API, and clarifies that ICH Q7 should be applied to mixtures classified as an API.
What is TOC & why it's measurement in production process usable water is important in the pharmaceutical industrial environment in respect to product quality
Role of bracketing & matrixing during stability studyMD. SELIM REZA
This document provides guidance on bracketing and matrixing designs for stability testing of drug substances and products. Bracketing involves testing samples only at the extremes of certain design factors, like strength or container size, at all time points. Matrixing involves testing a subset of all possible samples at each time point, assuming the stability of each subset represents all samples. The document defines when bracketing and matrixing can be applied and provides examples of design factors and sample designs. It notes that reduced designs may establish a shorter shelf life than a full design due to less collected data.
Guidelines for Preparing Laboratory Information FileMD. SELIM REZA
This document provides guidelines for preparing a Laboratory Information File (LIF) to describe the operations of pharmaceutical quality control laboratories. The LIF should include 13 sections that describe: general laboratory information; quality management systems; documentation control; personnel; premises; equipment; materials; subcontracting; sample handling; validation; out-of-specification investigations; stability testing; and microbiological testing, if applicable. The LIF is intended to be a concise yet comprehensive reference of approximately 30 pages that outlines all relevant aspects of the laboratory's quality system and operations.
QMS for setting a coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance.
To cater a green environment of manufacturing industries, reponsible persons or designee, higher management, owners should go through it and implement as required as their scope for safety, health, profitable business to global customer response.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
2. 158
• Any additional test results obtained on samples from the batch as
part of a periodic statistically based testing programme.
• A statement indicating whether the results were found to comply
with the requirements.
• The date(s) on which the test(s) was (were) performed.
• The signature of the head of the laboratory or an authorized
person.
• The name, address, and telephone and fax numbers of the original
manufacturer. If supplied by repackers or traders, the certificate
should show the name, address, and telephone and fax numbers of
the repacker/trader and a reference to the original manufacturer.
• A statement of the expected conditions of shipping, packaging,
storage and distribution, deviation from which would invalidate the
certificate.
• A copy of the certificate generated by the original manufacturer, if
the sample is supplied by a repacker or trader.
Reference
1. Good manufacturing practices for pharmaceutical products. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations. Thirty-second
report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical
Report Series, No. 823).
3. 159
Appendix 1
Model certificate of analysis for active
pharmaceutical ingredients, excipients and
medicinal products
Registration number of sample or certificate:
Name and address of laboratory testing the sample:
Sample information
Name of product (INN, brand name(s), etc.):
Dosage form (if applicable):
Marketing authorization number (if applicable):
Description (appearance of container and contents):
Batch number(s):
Required storage conditions:1
Date received: Date of manufacture:
Expiry date (for medicinal products) or retest date (for starting mate-
rials or excipients):
Name and address of original manufacturer:
Telephone: Fax:
4. 160
Name and address of repacker and/or trader (if applicable):
Telephone: Fax:
Test procedure (reference Result (numerical Acceptance criteria
to test procedure) result)2
(limits)
(if applicable) (if applicable)
A. Tests performed on
samples from batch for
which certificate is issued
B. Tests performed as
part of periodic
statistically based testing
programme
Conclusions:
Compliance with acceptance criteria: yesᮀ noᮀ
Date test performed/finalized:
Name and address of head of laboratory/authorized person:
Telephone: Fax:
Signature:
Explanatory notes
1
Statement of expected conditions of shipping, packaging, storage and distribution,
deviation from which could render the certificate invalid.
2
Indicate if the results were obtained from periodic statistically based testing.