WHO Annex 2 Good Manufacturing Practices for Pharmaceutical Products, 1/14

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The WHO Expert Committee on Specifications for Pharmaceutical Preparations published an update to Annex 2, Good Manufacturing Practices for Pharmaceutical Products: Main Principles in 2014. This document contains the collective views of an international group of experts including representatives from international regulatory agencies, EU, IFPMA, IGPA, IPEC, PIC/S, UNICEF, BSP and USP.

• Section 4, Qualification and Validation, outlines the expectations for pharma manufacturing validation programs, including validation of computers
• Section 8.2, Self-Inspection, contains the requirement to self-inspect validation and re-validation programs
• Section 14.13, Material Labeling, provides labeling exceptions when fully validated computerized systems are in use
• Section 15.9, Documentation, lists requirements for electronic data and records management
• Section 15.25, Batch Processing Records, and 15.28, Batch Packaging Records, contain recommendations to use validated computer programs
• Section 15.28, Batch Processing Records, outlines information that needs to be associated with a signature or electronic password
• Section 17, Good Practices in Quality Control, specifies responsibilities of the Quality Function, including roles in qualification and validation