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PIC/S Guide
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PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 指导原则 http://www.picscheme.org/publication.php?id=18 Document Reference Category Section PIC/S GMP GUIDE PE 009-11 Documents for industry PIC/S GMP Guide SITE MASTER FILE FOR PLASMA WAREHOUSES PI 020-3 Documents for industry PIC/S GMP Guide PIC/S GMP GUIDE (INTRODUCTION) PE 009-11 (Intro) Documents for industry PIC/S GMP Guide PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) PE 009-11 (Part I) Documents for industry PIC/S GMP Guide PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) PE 009-11 (Part II) Documents for industry PIC/S GMP Guide PIC/S GMP GUIDE (ANNEXES) PE 009-11 (Annexes) Documents for industry PIC/S GMP Guide EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE PE 008-4 Documents for industry Site Master Files SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS PI 019-3 Documents for industry Site Master Files PIC/S SCHEME PICS 1/95 (Rev 5) Documents for inspectorates Inspectorates PARTICIPATING AUTHORITIES & PARTNERS & (PRE)-APPLICANTS PS/INF 21/2002 (Rev 17) Documents for inspectorates Inspectorates PIC CONVENTION PIC Convention Documents for inspectorates Inspectorates QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PI 002-3 Documents for inspectorates Inspectorates PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS PI 010-4 Documents for inspectorates Inspectorates STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT PI 013-3 Documents for inspectorates Inspectorates STANDARD OPERATING PROCEDURE TEAM INSPECTIONS PI 031-1 Documents for inspectorates Inspectorates QA DISTRIBUTION ACTIVITIES FOR APIs - MAY 2010 PS INF 20 2011 Documents for inspectors Q&A Documents QA ON TRACEABILITY OF MEDICINAL GASES PS INF 06 2012 (Rev 1) Documents for inspectors Q&A Documents AIDE-MEMOIRE INSPECTION OF UTILITIES PI 009-3 Documents for inspectors Aide-Memoires AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS PI 021-2 Documents for inspectors Aide-Memoires AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES PI 023-2 Documents for inspectors Aide-Memoires AIDE MEMOIRE ON INSPECTION OF BIOTECH PI 024-2 Documents for inspectors Aide-Memoires AIDE-MEMOIRE ON MEDICINAL GASES PI 025-2 Documents for inspectors Aide-Memoires AIDE-MEMOIRE ON PACKAGING PI 028-1 Documents for inspectors Aide-Memoires AIDE-MEMOIRE ON THE INSPECTION OF APIS PI 030-1 Documents for inspectors Aide-Memoires AIDE MEMOIRE ON ASSESSMENT OF QRM IMPLEMENTATION PI 038-1 Documents for inspectors Aide-Memoires PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products PE 011-1 Documents for inspectors Guidance documents PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS PE 005-3 Documents for inspectors Guidance documents GUIDANCE ON PARAMETRIC RELEASE PI 005-3 Documents for inspectors Guidance documents VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION PI 006-3 Documents for inspectors Guidance documents VALIDATION OF ASEPTIC PROCESSES PI 007-6 Documents for inspectors Guidance documents PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE) PI 008-3 Documents for inspectors Guidance documents GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS PI 011-3 Documents for inspectors Guidance documents GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS (PE 010-4) PE 010-4 Documents for inspectors Guidance documents RECOMMENDATION ON STERILITY TESTING PI 012-3 Documents for inspectors Guidance documents ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING PI 014-3 Documents for inspectors Guidance documents TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE PI 032-2 Documents for inspectors Guidance documents PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING PI-037-1 Documents for inspectors Guidance documents PIC/S BROCHURE January 2014 Edition Documents for the public Information documents PIC/S BLUEPRINT PS W 8 2005 Documents for the public Information documents PRESS RELEASE MAY 2014 PR May 2014 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2013 PR Nov 2013 Documents for the public Press Releases PRESS RELEASE MAY 2013 PR May 2013 Documents for the public Press Releases PRESS RELEASE OCTOBER 2012 PR Oct 2012 Documents for the public Press Releases PRESS RELEASE MAY 2012 PR May 2012 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2011 PR Nov 2011 Documents for the public Press Releases PRESS RELEASE NO 2 JUNE 2011 PR 02 Jun 2011 Documents for the public Press Releases PRESS RELEASE NO 1 JUNE 2011 PR 01 Jun 2011 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2010 PR Nov 2010 Documents for the public Press Releases PRESS RELEASE MAY 2010 PR May 2010 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2009 PR Nov 2009 Documents for the public Press Releases PRESS RELEASE MAY 2009 PR May 2009 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2008 PR Nov 2008 Documents for the public Press Releases PRESS RELEASE MAY 2008 PR May 2008 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2007 PR Nov 2007 Documents for the public Press Releases PRESS RELEASE MAY 2007 PR May 2007 Documents for the public Press Releases PRESS RELEASE DECEMBER 2006 PR Dec 2006 Documents for the public Press Releases PRESS RELEASE JUNE 2006 PR Jun 2006 Documents for the public Press Releases PRESS RELEASE FEBRUARY 2005 PR Feb 2005 Documents for the public Press Releases PRESS RELEASE JUNE 2004 PR Jun 2004 Documents for the public Press Releases PRESS RELEASE NOVEMBER 2003 PR Nov 2003 Documents for the public Press Releases PRESS RELEASE JUNE 2003 PR Jun 2003 Documents for the public Press Releases PRESS RELEASE MAY 2002 PR May 2002 Documents for the public Press Releases ANNUAL REPORT 2013 AR 2013 Documents for the public Annual Reports ANNUAL REPORT 2012 AR 2012 Documents for the public Annual Reports ANNUAL REPORT 2011 AR 2011 Documents for the public Annual Reports ANNUAL REPORT 2010 AR 2010 Documents for the public Annual Reports ANNUAL REPORT 2009 AR 2009 Documents for the public Annual Reports ANNUAL REPORT 2008 AR 2008 Documents for the public Annual Reports ANNUAL REPORT 2007 AR 2007 Documents for the public Annual Reports ANNUAL REPORT 2006 AR 2006 Documents for the public Annual Reports ANNUAL REPORT 2005 AR 2005 Documents for the public Annual Reports ANNUAL REPORT 2004 AR 2004 Documents for the public Annual Reports ANNUAL REPORT 2003 AR 2003 Documents for the public Annual Reports ANNUAL REPORT 2002 AR 2002 Documents for the public Annual Reports ANNUAL REPORT 2001 AR 2001 Documents for the public Annual Reports ANNUAL REPORT 2000 AR 2000 Documents for the public Annual Reports ANNUAL REPORT 1999 AR 1999 Documents for the public Annual Reports EXAMPLE OF QUALITY RISK MANAGEMENT IMPLEMENTATION PS/INF 1/2010 Documents for the public Miscelleneous JOINT WORKSHOP PIC/S-PDA&ISPE Documents for the public Miscelleneous |
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- 附件 16 : PE_009-11_GMP_Guide_(Intro).pdf
- 附件 17 : PE_009-11_GMP_Guide_(Part_I_Basic_Requirements_for_Medicinal_Products).pdf
- 附件 18 : PE_009-11_GMP_Guide_(Part_II_Basic_Requirements_for_APIs).pdf
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- 附件 25 : pe-009-11-gmp-guide-xannexes.pdf
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- 附件 27 : pe-011-1-pics-gdp-guide.pdf
- 附件 28 : pi-002-3--recommendation-on-quality-system.pdf
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- 附件 71 : press-release-rome-2014-copy2.pdf
- 附件 72 : press-release-singapore-2007.pdf
- 附件 73 : pressreleaseuppsala2009.pdf
- 附件 74 : pr-may-2002.doc
- 附件 75 : ps-inf-06-2012-rev-1-qa-on-traceability-of-medicinal-gases.pdf
- 附件 76 : ps-inf-20-2011-qa-distribution-activities-for-apis---may-2010.pdf
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- 附件 78 : psinf012010exampleofqrmimplementation-copy1.pdf
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2楼2014-07-08 12:41:43
简单回复
florayo3楼
2015-02-24 22:30
回复
五星好评 
cdl09044楼
2015-11-01 20:54
回复
五星好评 谢谢分享
2016-10-22 16:45
回复
五星好评 顶一下，感谢分享！
