Direct Links to important GMP Validation Guidelines

APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000

This document is supposed to assist companies in the formulation of cleaning validation programmes

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APIC - Computer validation Guide, December 2002

This document provides guidance for the GMP-compliant use of computerised systems for the manufacture of an API or intermediate.

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FDA COMPLIANCE POLICY GUIDE Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

This Compliance Policy Guide explains the enforcement policy on the timing of the completion of certain validation activities for drug manufacturing and API manufacturing.

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FDA Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004

This guidance document describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on how the agency will implement this new section with respect to the submission of validation data in 510(k)s for reprocessed Single Used Devices

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WHO: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials

Compendium of WHO Guidelines: QS-Systems, HVAC-Systems, Validation, Inspections, Starting Materials, Sampling, Water for Pharmaceutical Produktion and Risk Analysis.

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WHO Supplementary guidelines on Good Manufacturing Practices: Validation

Guideline with focus on the overall concept of validation (API and Medicinal Products)

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FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

FDA now recommends implementation of quality assurance and quality control procedures that involve use of external control reagents beyond those provided by the test kit manufacturer in order to contribute to overall testing accuracy and therefore to blood safety.

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FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

ecommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

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FDA Guidance for Industry Validation of Procedures for Processing of Human Tissues Intended for Transplantation

Validation of Procedures for Processing of Human Tissues Intended for Transplantation

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Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES

Approaches to reduce impurities of the residual host DNA and host cell proteins in biotevchnical products during the downstrean process

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GMP Conferences by Topics

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