Direkt Links to important GMP Biologic Guidelines

ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

ICH guidelines for the quality of biotechnology products with respect to the specification of new biotechnology substances. With this guideline concerning specifications for biotechnology products ICH (Japan, USA, EU) intends to define uniform standards for the specifications of biotechnology products.

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FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983

This guideline of the National Center for Drugs and Biologics does not primarily address the industry but is intended as a training aid for FDA inspectors. Although no longer completely up to date, it is of interest to all who are responsible for hard- and software.

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EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use

Supplementary guidelines to the EC-GMP Guide with specific requirements for the manufacture of biological medicinal products for use in humans.

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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 Microbiological Pharmaceutical Quality Control Laboratories, 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 microbiological QC laboratories. This guide supplements the Guide to Inspection of Pharmaceutical Quality Control Laboratories of July 1993 and goes into greater depth about the points an FDA inspector should check and inquire about in a microbiological laboratory.

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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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21 CFR Part 600 Biological Products: General

US GMP requirements for the manufacturer of Biological Products

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21 CFR Part 610 General Biological Products Standards

General Biological Products Standards of the FDA

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FDA Guidance for Industry: Q9: Quality Risk Management

This guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products

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FDA Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications

Environmental Assessment of Human Drug and Biologics Applications

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GMP Conferences by Topics

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