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. Cross-reference of APIC QMS documents (from old to new ) 5. Assistance for implementation of a QMS 6.
The common requirements in both standards (such as continual improvement of the processes, training, auditing and documentation) will facilitate auditing, and integration, if desired by an organization. Conclusion One can easily infer that the ISO 9001:2000 series are an excellent complementary fit to the GMP
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