搜了一下园好象没有.








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" - Interpretation 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 Memoire
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
很好!!