Quality Management System

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Quality Management SystemforActive pharmaceuticalIngredients manufacturers Integrating GMP into ISO 9001December 1997Quality Management System - integrating GMP into ISO1Table of and development of customer-supplied and equipment identification and process and of inspection, measuring and test and test of nonconforming and preventive , storage, packaging, preservation and of Quality Quality A: B: Facilities and cleaning, utilities and C: D: Change and System performance Management System - integrating GMP into ISO2A. AcknowledgementsThe BPCC, a sector group of CEFIC acknowledges the following documents which have beenused as basis for the establishment of the present guideline:-EFPIA/CEFIC Good Manufacturing Practices for Active Ingredient Manufacturerspublished in August 1996, and- EN ISO 9001 Quality Systems: Model for Quality Assurance in Design, Development,Production, Installation and Servicing published in July members of the BPCC ad hoc working group who developed and prepared this documentare as follows: W.

Quality Management System - integrating GMP into ISO 6 Change control Formal system to evaluate effects of any change. Computer system A system including the input of data, electronic processing and the output of information to be

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