GMP News No 119
19 July 2001
4 New Annexes to EC GMP Guide Finalised
The Working Party on Control of Medicines and Inspections has finalised 4 new annexes. In the following you can download the new annexes.
This annex is a revision to the current annex on Manufacture of Medicinal Gases. It is meant to replace current requirements from September 2001.
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This new guideline deals with qualification and validation. It is based on the PIC document PH 1/99. However, it has been changed in some parts and considerably abridged. It is also due to come into operation in September 2001.
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This guideline is also new and concerns the subject of 'Qualification by a Qualified Person and Batch Release.' These requirements will come into force in January 2002. They are of great interest above all to contract manufacturers, but also to companies which carry out production steps in different locations.
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January 2002 will also be the date for this new annex to come into effect. It is about parametric release, a topic which has been discussed extensively for economic reasons by industry and authorities.
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