Direkt Links to important GMP Biologic Guidelines

Eudralex Volume 3 NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES

the guidance concerns the validation of virus inactivation and/or removal prcedures for all categories of medicinal biological products for human use with the exception of live virel vaccines including genetically engineerd live vectors.

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Eudralex Volume 3 Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

This reflection paper discusses how the microbiological contamination can be limited by preventative measures and decontamination processes.

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FDA FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we

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FDA Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

This document is intended to provide guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) requirements.

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FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

This guidance document provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.

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FDA Guidance for Industry: Indexing Structured Product Labeling

This guidance explains that FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will index the content of labeling for human drug and biological products using SPL (Structured Product Labeling).

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FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes

This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other post-marketing report

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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile 56 Products: Microbial Enumeration Tests.

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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile 56 Products: Tests for Specified Micro-organisms.

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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharm

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: 57 Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.

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GMP Conferences by Topics

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