Transcription of Quality Management System
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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. Description of processes 3. Structure of a Quality Manual 4.
Because the pharmaceutical industry has traditionally focused upon the application of Good Manufacturing Practice (GMP), it has been slow to consider the potential benefits to be gained by implementing an EN ISO 9001 Quality Management System (QMS). Over the last few years the global pharmaceutical market has undergone significant change, forcing
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