|
The Working Party on Control of Medicines and Inspections
has finalised 4 new annexes. In the following you can download the new
annexes.
- Annex 6
This annex is a revision to the current annex on Manufacture of
Medicinal Gases. It is meant to replace current requirements from September
2001.
Click
here in order to download it.
- Annex 15
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.
Please
click here to download. - Annex
16
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.
A
click will start the download. - Annex
17
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.
Just
click
to download the document.
|
