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1. GDP Audit Checklist
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Standard draft to adapt and extend

 

3. Premises
Official requirements | material flow | room classes | and much more...

 

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for Pharmaceutical and API Manufacturers

 

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A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience

 

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News about GMP/cGMP

2011-01-11

PIC/S: Revised Site Master File

At its meeting in Kuala Lumpur in November 2010, the PIC/S Committee has adopted the revision of the "Explanatory Notes for Industry on the Preparation of a Site Master File". The new document comes in force on January 01, 2011.

 

Aim of the revision were the simplification of the document and the implementation of requirements in relation with quality risk management.

Outcome:

The revised document enters in force on January 01, 2011. You can download the document here.

Links:

PIC/S/ Announcement

PIC/S Site Master File

Comments
Thanks. I got the good information regarding PICs SMF the current guideline.
Siva Sahu 2011-01-17