TRS 996 - Annex 3: WHO good manufacturing practices for biological products (jointly with the Expert Committee on Biological Standardization)

Overview

This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14). The content of this document should be considered complementary to the general recommendations 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. If a national regulatory authority (NRA) so desires, the guidance provided may be adopted as definitive national requirements, or modifications may be justified and made by the NRA in light of the risk–benefit balance and legal considerations in each authority. In such cases, it is recommended that any modification to the principles and technical specifications set out below should be made only on the condition that the modifications ensure product quality, safety and efficacy that are at least equivalent to that recommended in this document.