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PHSS Technical Monograph No.2 (revised 2002)

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Environmental Contamination Control Practice REVISED 2002

This Monograph was originally compiled in 1989 in response to requests from The Pharmaceutical and Healthcare Sciences Society membership for more specific guidance on environmental control practice than that which was available in cleanroom standards and in the publications on Good Manufacturing Practice. It has been updated to recognize the publication of new cleanroom standards from CEN and ISO, the developments in the EU GMP, work of the PIC/S, the evolution of requirements from the US FDA and developments in engineering practice. This Monograph should be used in conjunction with GMP guidance and CEN and ISO standard documents. The emphasis is on pragmatic guidance. Users are encouraged to carry out studies to develop their own operational control and monitoring standards. The Monograph is especially applicable to situations where insufficient data are available in-house and where new or altered premises have been brought into operation. The target levels for contamination specified in the document apply to areas in which sterile pharmaceutical products are processed and are not necessarily applicable to other situations. However, the monograph may be of use when searching for a contamination control solution for other processes and dosage forms.

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