(2003; 148 pages)
9.2 Application of hazard analysis and critical control point methodology for pharmaceuticals
The Committee was briefed about the content of a document on the application of the hazard analysis and critical control point (HACCP) system to pharmaceuticals. It noted that the document provided general guidance on the use of HACCP to ensure the quality of pharmaceuticals, while recognizing that the details may vary depending on the circumstances. It was emphasized to the Committee that HACCP does not replace GMP but focusses on the prevention of hazards. The Committee was also informed that HACCP should not be confused with validation.
The Committee adopted the document “Application of Hazard Analysis and Critical Point (HACCP) Methodology for Pharmaceuticals” subject to: (1) the addition of a statement or addendum on the use of HACCP in other industries; and (2) some minor editorial changes being made in relation to consistency in the use of terms (e.g. “pharmaceuticals”, “pharmaceutical finished products”, “finished products”) (Annex 7).