Direct Links to important GMP Validation Guidelines

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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FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility

FDA is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices

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EU GMP Annex 15: Qualification and Validation

principles of qualification and validation

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Eudralex Volume 3 Guideline on process validation for finished products - information and data to be provided in regulatory submissions

his guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.

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Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (draft)

This guideline addresses the data requirements for the validation of biotech manufacturing processes for submission of a marketing authorisation application or variation.

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FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

This guideline addresses the data requirements for the validation of biotech manufacturing processes for submission of a marketing authorisation application or variation.

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Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus

• Clinical experience with HEV infections and transfusion-associated infections: How serious are HEV infections and which patient populations may be particularly at risk? • HEV detection and epidemiology of HEV in blood/plasma donations • Do serum antibodies against HEV significantly neutralise? • Latest experience from studies on inactivation/removal of HEV: Which steps are effective to remove / inactivate HEV? Which model viruses can be used to assess that? Do we need more virus validation data?

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APIC - GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS

The document reflects the outcome of discussions between APIC member companies on how cleaning validation requirements could be fulfilled and implemented as part of routine operations.

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Eudralex Volume 3 Guideline on process validation for finished products - information and data to be provided in regulatory submissions

This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.

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GMP Conferences by Topics

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