Final Draft of Annex 15 published!

GMP News Nr. 97

GMP News
March 1, 2001


Final Draft of Annex 15 published!

Early in December 2000 the working group elaborating Annex 15 approved its final draft.

This document has now been published on the internet. The document shows that it will become valid from June 2001. Before that, the EC, which was always informed of the individual revisions, has to give its approval. This step is considered more as a formality.  

Compared to the other annexes, Annex 15 is relatively short. The original draft, which was still very heavily based on PIC/S document PR 1/99-1 was 29 pages long. The final draft now comprises 11 pages and contains 9 chapters: 

  • Qualification and validation
  • Planning for validation
  • Documentation
  • Qualification
  • Process validation
  • Cleaning validation
  • Change control
  • Revalidation
  • Glossary

A real innovation in Annex 15 is the requirement for a risk assessment. The targets and extent of the validation work are to be planned on the basis of the risk assessment. Methods for a risk assessment are, however, not named. 

The design validation is only mentioned as a "could be" of the first stage of a qualification. 

Unlike PIC/S document PR 1/99-1, the chapter on process validation is not directed only  towards non-sterile processes. 

The correct mention of 10-30 batches as the extent for a retrospective validation is also new. The naming of this value represents a “harmonization” with the FDA requirements. Comparable numerical values can be derived from the Barr ruling. 

The performance qualification (PQ) is again mentioned as an independent qualification stage and is not equalled with process validation as is the case with PIC/S document PR 1/99-2. 


Annex 15 in its present form is a document which, comparable to the other annexes, gives only the target while leaving the path to the target open to the companies.  

If you are in need of support here you will find additional information in PIC/S document PR 1/99-2. 

The statement by John Dietrick, CDER, FDA who finds Annex up to date and suggested that a validation study, based on Annex 15, should also be accept by FDA is particularly pleasing. 

06/02/01 Draft revised version of
Annex 15 of the GMP: Validation master plan : Design qualification, installation and operational qualification, non-sterile process validation, cleaning validation for information.
Gold Sheet, Vol 27, No 2, February, 1993
Lyda, James, PDA Letter, Vol. XXXVI, No 12, 21 (2000)


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