Analytical methods for hazard and risk analysis are being considered for controlling contamination\ud in pharmaceutical cleanrooms. The most suitable method appears to be the HACCP system that has\ud been developed for the food industry, but this requires some reinterpr... View more
1. The Rules Governing Medicinal Products in the European Union. Volume 4. 'Good manufacturing practices - Medicinal products for human and veterinary use'.
2. Draft ISO 14698-1. 'Cleanrooms and associated controlled environments-biocontamination Control': Part 1: 'General principles and methods', 2001.
3. IEC 61025-1990, Fault Tree Analysis (FTA). Geneva, Switzerland: International Electrotechnical Commission, 1990.
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