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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

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


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


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


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


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News about GMP/cGMP

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.


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


PIC/S/ Announcement

PIC/S Site Master File

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