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. Procedures, including GMP, address operational conditions and provide the basis for HACCP. HACCP is a systematic method for the identification,
assessment and control of safety hazards. Such hazards are defined as biological, chemical, or physical agents or operations that are reasonably likely to cause illness or injury if not controlled. In the manufacture of pharmaceuticals, these may include the manufacture of certain antibiotics, hormones, cytotoxic substances or other highly active pharmaceuticals, together with operations such as fluidbed drying, granulation is an example of hazard unit operations. The use of
inflammable solvents (solutions) and certain laboratory operations may also
The present guidelines are aimed at assisting industry to develop and implement effective HACCP plans covering activities such as research and development, sourcing of materials, manufacturing, packaging, testing and distribution.