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1. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

2. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

4. Risk Management
Apart from factual content you will find many tables, examples, forms, which can be used in daily practice.

 

5. Documenting Process Validation – A Drugmaker’s Guide
Document process validation in a way that’s sure to satisfy – and impress – regulators.

 

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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