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APIC(ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE) 指南免费下载
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In this section you will find all the publications prepared by APIC. Those documents can be downloaded as a pdf file. APIC list of Abbreviations & Acronyms Industry Best Practice documents: Good Manufacturing Practices for Active Ingredients Manufacturers, with EFPIA, 1996 Quality System for Active Ingredients Manufacturers, integrating GMP into ISO, 1997 Manufacture of Sterile Active Pharmaceutical Ingredients, guidance, 1999 Cleaning validation in Active Ingredient Manufacturing plants – Policy, 1999 Good manufacturing practices in Active Pharmaceutical Ingredients development, 1999 Cleaning validation in active pharmaceutical plants – guidance, 2000 "How to do" - Interprétation of ICH Q7A document & "Review Form" Computer Validation Guide, December 2002 Auditing Guide, August 2002 Appendix A - Auditing Guide Secrecy Agreement Appendix B - Auditing Guide Questionnaire Appendix C - Auditing Guide Aide Mémoire Appendix D - Auditing Guide Audit Report Template Audit Programme, September 2006 Parametric release document, December 2002 Qualification of existing equipment 2004 Technical Change Control Guideline 2004 Quality Management System (QMS) for APIs 2005 Disclaimer: These documents represent the views of APIC members only and do not constitute a formal regulatory guidance. http://www.apic.cefic.org/publications/publications.html |
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