|
BS ISO 27001-2005 Information technology-Security techniques |
ISO |
global |
18 Oct 2005 |
|
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems |
ISPE |
global |
29 Feb 2008 |
|
ICH Q10 Pharmacutical Quality System |
ICH |
global |
4 Jun 2008 |
|
ICH Q2(R1) Validation of Analytical Procedures |
ICH |
global |
30 Nov 2005 |
|
ICH Q3C(R3) Impurities - Guideline for Residual Solvents |
ICH |
global |
30 Nov 2005 |
|
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients |
ICH |
global |
10 Nov 2000 |
|
ICH Q9 Quality Risk Management |
ICH |
global |
9 Nov 2005 |
|
ISO 10648-1:1997 Containment enclosures-Part 1: Design principles |
ISO |
global |
1 May 1997 |
|
ISO 10648-2:1994 Containment enclosures-Part 2: Classification according to leak tightness and associated checking methods |
ISO |
global |
1 Dec 1994 |
|
ISO 14644-1-1999 Cleanrooms and associated controlled environments-Part 1 Classification of air cleanliness |
ISO |
global |
15 Aug 1999 |
|
ISO 14644-2-2000 Cleanrooms and associated controlled environments-Part 2 Specifications for testing and monitoring |
ISO |
global |
15 Dec 2000 |
|
ISO 14644-3-2005 Cleanrooms and associated controlled environments-Part 3 Test methods |
ISO |
global |
20 Dec 2005 |
|
ISO 14644-4-2001 Cleanrooms and associated controlled environments-Part 4 Design, construction and start-up |
ISO |
global |
15 Sep 2001 |
|
ISO 14644-5-2004 Cleanrooms and associated controlled environments-Part 5 Operations |
ISO |
global |
20 Aug 2004 |
|
ISO 14644-6-2007 Cleanrooms and associated controlled environment-Part 6 Vocabulary |
ISO |
global |
31 Aug 2007 |
|
ISO 14644-7-2004 Cleanrooms and associated controlled environments-Part 7 Separative devices |
ISO |
global |
14 Aug 2008 |
|
ISO 14644-8-2006 Cleanrooms and associated controlled environments-Part 8 Classification of airborne molecular contamination |
ISO |
global |
29 Sep 2006 |
|
ISO 9000-2005 Quality management systems - Fundamentals and vocabulary |
ISO |
global |
29 Sep 2005 |
|
ISO 9001-2008 Quality management systems - Requirements |
ISO |
global |
30 Nov 2008 |
|
ISO 9004-2000 Quality management systems - Guidelines for performance improvements |
ISO |
global |
15 Dec 2000 |
|
ISPE - Commissioning and Qualification Baseline Guide |
Commissioning, Qualification |
global |
1 Mar 2001 |
|
PE008-3 Explanatory Notes for Industry on the Preparation of a Site Master File |
PICS |
global |
25 Sep 2007 |
|
PE009-8 Guide to Good Manufacturing Practice for Medicinal Products-Annexes |
PICS |
global |
15 Jan 2009 |
|
PE009-8 Guide to Good Manufacturing Practice for Medicinal Products-Introduction |
PICS |
global |
15 Jan 2009 |
|
PE009-8 Guide to Good Manufacturing Practice for Medicinal Products-Part II |
PICS |
global |
15 Jan 2009 |
|
PE009-8 Guide to Good Manufacturing Practice for Medicinial Products-Part I |
PICS |
global |
15 Jan 2009 |
|
PE010-3 Guide to Good Manufacturing Practice for Products of Medicinal Products |
PICS |
global |
1 Oct 2008 |
|
PI0010-3 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects |
PICS |
global |
26 Sep 2007 |
|
PI0011-3 Good Practices for Computerised Systems in Regulated “GXP” Environments |
PICS |
global |
25 Sep 2007 |
|
PI0012-3 Recommendation on Sterility Testing |
PICS |
global |
25 Sep 2007 |
|
PI0014-3 Isolators used for Aseptic Processing and Sterility Testing |
PICS |
global |
25 Sep 2007 |
|
PI005-3 Guidance on Parametric Release |
PICS |
global |
25 Sep 2007 |
|
PI006-3 Validation Master Plan |
PICS |
global |
25 Sep 2007 |
|
PI007-4 Validation of Aseptic Processes |
PICS |
global |
7 Feb 2009 |
