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CDRH Guidance SOP development

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 This paper summarizes the Center for Devices and Radiological Health's (CDRH) guidance development process.

PIC's: Site Master File

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PIC'S: These Explanatory Notes apply to the preparation and content of the "Site Master File"
Simplification of the document and implementation requirements for the evaluation of Quality Risk

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.

BPF: Chapter 4

Revision January 2011 for implementation in June 30 2011

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Sections "production and documentation control"And"document retention"
have been revised in the light of the increasing use of electronic documentation
within the 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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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               youtube channel   linkedin