WHO TRS (Technical Report Series) 908, 2003 Annex 7

Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals

1. Introduction:

Traditionally, the Hazard Analysis and Critical Control Point (HACCP) methodology has been considered to be a food safety management system. It aims to prevent known hazards and to reduce the risks that they will occur at specific points in the food chain. The same principles are also increasingly being applied, in other industries, such as the car industry, aviation and the chemical industry. 

This text provides general guidance on the use of the HACCP system to ensure the quality of pharmaceuticals, while recognizing that the details of its application may vary depending on the circumstances (see Appendix 1). It does not provide detailed information on major hazards. 

Hazards affecting quality are controlled to a certain extent through the validation of critical operations and processes in the manufacture of finished pharmaceutical products in accordance with Good Manufacturing Practices (GMP). However, GMP do not cover the safety of the personnel engaged in manufacture, while both aspects are covered by HACCP. 

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WHO TRS (Technical Report Series) 908, 2003 Annex 7: