...Annex 15 coming....Annex 15 coming....

The 15^th Supplementary Guideline to the EC-GMP Guide (Annex 15), dealing with the topic of validation and qualification, has already been available in draft form for one year now (see GMP News of 19 January 2000 and of 21 November 2000). Comments were invited for this draft until spring of last year.

The Final Draft was approved in the December 2000 meeting of the Working Group concerned with Annex 15.

Now what are the other items on the agenda?

First of all this document will be returned to the PIC/S. Then the approval of the EC, which was always informed of the various revisions, has to be obtained. This step is regarded rather as a mere formality and can probably take place already at the next meeting of the Working Group in February 2001.

After that, Annex 15 could enter into effect as early as June 2001.

• The content of Annex 15 is still confidential. It is, however, known that the
• industrial comments have been included
• no new requirements have been added

• Annex 15 will be relatively short in comparison with the other annexes (the PIC/S Document PR 1/99-2 will continue to be available for further interpretation), and that

• the definitions have been standardized.