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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 andmethod of manufacture. The source materials and methods employed in themanufacture of biological products for human use therefore represent criticalfactors in shaping their appropriate regulatory control. Biological products arederived from cells, tissues or microorganisms and reflect the inherent variabilitycharacteristic of living materials. The active substances in biological productsare  often too complex to be fully characterized by utilizing physicochemicaltesting methods alone and may show a marked heterogeneity from onepreparation and/or batch to the next. Consequently, special considerationsare needed when manufacturing biological products in order to maintainconsistency in product quality.Good manufacturing practices (GMP) for biological products werefirst published by WHO in 1992 (1). This current revision reflects subsequentdevelopments that have taken place in science and technology, and in theapplication of risk-based approaches to GMP (2–14). The content of thisdocument should be considered complementary to the general recommendationsset out in the current WHO good manufacturing practices for pharmaceuticalproducts: main principles (2) and in other WHO documents related specificallyto the production and control of biological products.This document is intended to serve as a basis for establishing nationalguidelines for GMP for biological products. If a national regulatory authority(NRA) so desires, the guidance provided may be adopted as definitive nationalrequirements, or modifications may be justified and made by the NRA in lightof the risk–benefit balance and legal considerations in each authority. In suchcases, it is recommended that any modification to the principles and technicalspecifications set out below should be made only on the condition that themodifications ensure product quality, safety and efficacy that are at leastequivalent to that recommended in this document.

2. Scope

The guidance provided in this document applies to the manufacture, controland testing of biological products for human use – from starting materialsand  preparations (including seed lots, cell banks and intermediates) to thefinished product.Manufacturing procedures within the scope of this document include:■ growth of strains of microorganisms and eukaryotic cells;■ extraction of substances from biological tissues, including human,animal and plant tissues, and fungi;...

For more information, please refer to: http://www.who.int/biologicals/areas/vaccines/Annex_2_WHO_Good_manufacturing_practices_for_biological_products.pdf