Direct Links to important GMP Validation Guidelines

Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared faciliti

The document interpretats the EMA Guideline on setting health based exposure limits... (EMA/CHMP/CVMP/SWP/169430/2012)

FDA Guidance for Industry: Bioanalytical Method Validation

This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation

ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation - Final Concept Paper

FDA Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures

This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files.

FDA Guidance for Industry: Q2(R2) Validation of Analytical Procedures

This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological / biotechnological).

The IPEC Validation Guide for Pharmaceutical Excipients

This document provides guidance on the validation of excipient processes and product.

WHO Good Practices for research and development facilities of pharmaceutical products

This guideline is specifically applicable to research and development facilities of pharmaceutical products, procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, technology transfer-related activities (15), validation (7), quality control laboratory activities such as stability testing and development (16), and validation of cleaning procedures

WHO Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

Determination of HBELS

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