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International Organization for Standardization, Quality Management Systems-Requirements, ISO 9001:2000, American National Standards Institute ANSI/ISO/ASQC Q9001-2000.

International Organization for Standardization, Quality Management Systems - Fundamentals and Vocabulary, ISO 9000:2000.

International Organization for Standardization, Food safety management systems – Requirements for organisations throughout the food chain, Draft International Standard ISO/DIS 22000.

International Pharmaceutical Excipients Council Good Manufacturing Practices Guide For Bulk Pharmaceutical Excipients, 2001.

International Pharmaceutical Excipients Council of the Americas Good Manufacturing Practices Audit Guideline for Bulk Pharmaceutical Excipients, 2004.

International Pharmaceutical Excipients Council of the Americas Certificate of Analysis Guide Bulk Pharmaceutical Excipients, 2000.

International Pharmaceutical Excipients Council of the Americas Significant Change Guide Bulk Pharmaceutical Excipients, 2005.

Institute of Quality Assurance, Pharmaceutical Quality Group PS 9100:2002 Pharmaceutical excipients, an application standard and GMP guide for pharmaceutical excipients, 2002.

Institute of Quality Assurance, Pharmaceutical Quality Group, Monograph No 5, Pharmaceutical Auditing, 2001.

WHO Technical Report Series No. 917, 2003 Annex 2, Good trade and distribution practices for pharmaceutical starting materials.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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