domingo, 27 de junho de 2010

PARA LER - ENVIRONMENTAL MONITORING PROGRAMS

PDA - 2001 - PDA Tech Report #13 (Revised): Fundamentals of an Environmental Monitoring Program
EU-2008 - Eudralex The Rules Governing Medical Products in the European Union Volume 4: EU Guidelines to Good Manufacturing Practice Medical Products for Human and Veterinary Use: Annex 1 Manufacture of Sterile Medical Products.
PICS, 2004. PI-006-2 - Recomendations on VMP, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation.
USP 1116 - Microbioogical Control and Monitoring Environments Used for the Manufacture of Healthcare Products

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