Direkt Links to important GMP Validation Guidelines

FDA Reviewer Guidance: Validation of Chromatographic Methods, 1994

This FDA Reviewer Guidance is specifically directed at those FDA officials who check the dossiers for a marketing authorisation and gives instructions on which requirements should be made to the validation of analytical chromatographic methods. It contains many details concerning the system suitability test.

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PIC/S Validation of Aseptic Processing (PI 007-6) 2011

Detailed recommendations on the validation of aseptic processes, relating to different drug formulations including statistic limits. The document refers to ISO 13408-1.

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FDA Guide to Inspections of Oral Solutions and Suspensions, August 1994

These guidelines of ORA within FDA are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of liquid oral preparations and suspensions. The following topics are addressed therein: premises and equipment, requirements for starting materials, manufacturing methods, microbial quality, homogeneity of suspensions, specifications, stability, packaging and process validation.

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FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 1994

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of solid oral dosage forms. This document addresses many problems in the validation of solid dosage forms. It distinguishes between prospective and retrospective validation. This guideline also deals with the inofficially required Product Development Report and lists the information that should be given therein. The advantages and disadvantages of some actual mixer types are also dealt with.

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FDA Guide to Inspections of Validation of Cleaning Processes, July 1993

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of the validation of cleaning methods (cleaning validation)

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FDA Guide to Inspections of High Purity Water Systems, July 1993

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of water systems both for purified water and for water for injection (WFI). From the microbiological point of view they deal especially with the evaluation of water treatment systems, technical issues and the validation of water systems.

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FDA Guide to Inspections of Topical Drug Products, July 1994

These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. You will find here guidelines for the inspection of manufacturers of topical forms (emulsions, creams, ointments). Topics addressed are: uniformity of active substance content, equipment for production, cleaning validation, microbiological controls, change control and transdermal topical products.

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FDA Sterilization Process Validation, January 1993

These FDA guidelines for the validation of sterilization methods were compiled by the Center for Veterinary Medicine and by the Center for Drug Evaluation and Research. They contain recommendations as to which information about the validation of the sterilization methods used must be communicated to FDA when applying for marketing authorization for human and veterinary medicinal products.

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Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation

This guideline is intended to provide guidance in the process of calibration, validation and maintenance of a Near Infrared Spectroscopy (NIRS) method and the type of data to be submitted to the competent authorities in the case that NIRS is subject or part of an application.

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FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Guideline for industry and FDA Staff for the validation of software regarding medical devices

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GMP Conferences by Topics

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