Transcription of WHO good manufacturing practices for biological products
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WHO good manufacturing practices for biological products
93 Annex 2 WHO good manufacturing practices for biological productsReplacement of Annex 1 of WHO Technical Report Series, No. 8221. Introduction 962. Scope 963. Terminology 1004. Principles and general considerations 1045. Pharmaceutical quality system and quality risk management 1066. Personnel 1067. Starting materials 1078. Seed lots and cell banks 1099. Premises and equipment 11110. Containment 11311. Clean rooms 11512. Production 11613. Campaign production 11814. Labelling 11915. Validation 11916. Quality control 12117. Documentation (batch processing records) 12218.
set out in the current WHO good manufacturing practices for pharmaceutical products: main principles (2) and in other WHO documents related specifically to the production and control of biological products. This document is intended to serve as a basis for establishing national guidelines for GMP for biological products.
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