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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GMP Conferences by Topics

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