Direkt Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Process Validation: General Principles and Practices

This guidance outlines the general principles and approaches that FDA considers to be 21 appropriate elements of process validation for the manufacture of human and animal drug and 22 biological products, including active pharmaceutical ingredients (API or drug substance),

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ICH Q4B Annex 4A(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

The ICH Steering Committee recommends that the official pharmacopoeial texts of Ph.Eur, USP, and JP can be used interchangeable in the ICH regions.

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ICH Q4B Annex 4B(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter

The ICH Steering Committee recommends that the official pharmacopoeial texts of Ph.Eur, USP, and JP can be used interchangeable in the ICH regions.

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ICH Q4B Annex 4C(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use Genera

The ICH Steering Committee recommends that the official pharmacopoeial texts of Ph.Eur, USP, and JP can be used interchangeable in the ICH regions.

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Eudralex Volume 3 ICH Topic Q4B Annex 4 A 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 Products: Microbial Enumeration Tests.

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Eudralex Volume 3 ICH Topic Q4B Annex 4 B 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 Products: Tests for Specified Micro-organisms.

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Eudralex Volume 3 ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

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

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FDA Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format — General Considerations

This guidance document is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD.

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FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics - Questions and Answers

This document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance).

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FDA Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

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GMP Conferences by Topics

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