Rules and Guidance for Pharmaceutical Manufacturers

Anon. 997)Rules and Guidance for Pharmaceutical Manufacturers. London The Stationery Office and Dishibutors. (3)... 

Areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate level of microbial and particulate cleanliness four grades (Table 22.1) are specified in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997), defined by measures of airborne contamination (Table 22.2). Environmental quality is substantially influenced by the air supplied to the manufacturing environment. 

Medicinal Products in 1989 and are now published in the UK as Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) by the Medicines Control Agency, Department of Health. 

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) London HMSO. Spooner D.F. (1996) Hazards associated with the microbiological contamination of cosmetics, toiletries andnon-sterile pharmaceuticals. Iw.Microhial Quality Assurance in Cosmetics, Toiletries andNon-sterile Pharmaceuticals, 2nd edn (eds R.M. Baird S.F. Bloomfield), pp. 9-27. London Taylor Francis. 

MCA Rules and Guidance for Pharmaceutical Manufacturers and Distributors, L997. 

Rules and Guidance for Pharmaceuticals Manufacturers (2002), Her Majesty s Standards Office (U.K.). 

Medicines Control Agency (MCA) (1997) Rules and guidance for pharmaceutical manufacturers and distributors. The Stationary Office, PO Box 276, London, UK. 

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