Direct Links to important GMP Sterile & Aseptic Processing Guidelines

ICH Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test 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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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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Eudralex Volume 3 Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution CPMP/QWP/ 159/96 Corr.

This guidance relates to the time between the product and time of administration ot the patient

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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 8: Sterility Test General Chapter

This annex is the result of the Q4B process for the Sterility Test General Chapter

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FDA COMPLIANCE POLICY GUIDE Sec. 490.200 Parametric Release - Parenteral Drug Products Terminally Sterilized by Moist Heat

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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Eudralex Volume 3 ICH Topic Q4B Annex 8 Sterility Test General Chapter

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WHO Guideline on Validation (Annex 7: non-sterile process validation)

Revision des Anhangs 7 der WHO Guideline über Prozess Validierung, Teil Validierung der Herstellung nicht steriler Arzneimittel

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WHO good practices for pharmaceutical microbiology laboratories (Annex 2, TRS 961)

These guidelines relate to all microbiology laboratories involved in sterility Testing; detection, isolation, enumeration and identification of microorganisms and assay activities, whether they are independent or a department or unit of a pharmaceutical manufacturing facility.

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GMP Conferences by Topics

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