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GMP: Chapter 4




Reasons for changes: The sections on "generation and control of documentation"And"retention of records"Have-been revised, in the light of the Increasing use of electronic document dans le GMP environment.

FDA: Guidance for Industry Process Validation-: General Principles and Practices

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This guidance aligns process validation activities with a product lifecycle concept and with Existing FDA guidance, Including the FDA / International Conference on Harmonisation (ICH) guidances for industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and

Q10 Pharmaceutical Quality System.

Although this guidance Does not repeat the concepts and principles Explained In Those guidances, FDA encouraged the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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