Direct Links to important GMP Computer Validation Guidelines

FDA COMPLIANCE POLICY GUIDE Sec. 425.400 Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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FDA COMPLIANCE POLICY GUIDE Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records (CPG 7132a.08)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility

FDA is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices

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APIC - Guideline for the Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerised Systems and Facilities used in the Manufacture of APIs and Intermediates revised Nov.2018

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FDA Guidance for Industry: Computer Software Assurance for Production and Quality System Software

FDA is issuing this draft guidance to provide recommendations on computer software assurance 17 for computers and automated data processing systems used as part of medical device production 18 or the quality system

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Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems

This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

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