Direct Links to important GMP Validation Guidelines

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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Personalized Medical Devices – Production Verification and Validation

The purpose of this IMDRF guidance is to provide harmonized recommendations for verification and validation aspects of a patient-matched medical device and a medical device production system (MDPS).

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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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Good manufacturing practices: guidelines on validation

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

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FDA Guidance for Industry: BIOANALYTICAL METHOD VALIDATION

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples

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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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GMP Conferences by Topics