WHO good manufacturing practices for biological products

Replacement of Annex 1 of WHO Technical Report Series, No. 822

1. Introduction:

Biological products can be defined according to their source material and method of manufacture. The source materials and methods employed in the manufacture of biological products for human use therefore represent critical factors in shaping their appropriate regulatory control. Biological products are derived from cells, tissues or microorganisms and reflect the inherent variability characteristic of living materials. The active substances in biological products are often too complex to be fully characterized by utilizing physicochemical testing methods alone and may show a marked heterogeneity from one preparation and/or batch to the next. Consequently, special considerations are needed when manufacturing biological products in order to maintain consistency in product quality.

Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). 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.

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Table of Contents

1. Introduction

2. Scope

3. Terminology

4. Principles and general considerations

5. Pharmaceutical quality system and quality risk management

6. Personnel

7. Starting materials

8. Seed lots and cell banks

9. Premises and equipment

10. Containment