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Quality Management System

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 APIC / CEFIC Quality Management System - integrating GMP (ICH Q7a) into ISO (9001: 2000) Page 2 of 73 Table of Contents I. Introduction II. Objective and Scope III. Quality Management Systems for API manufacturers 1. Quality Management System 2. Management responsibility 3. Resource Management 4. Product realization (Manufacturing Operations) 5. Measurement, analysis and improvement (Evaluation Activities) IV. Supplementary Information 1. Identification of System approaches in Q7a 2.

• the EFQM Business Excellence Model • the Balanced Score Card Approach Compatibility with other management systems The standard has been made compatible with ISO 14001:1996 “Environmental management systems – Specification with guidance for use” and should assist users in implementing (and certifying) both

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