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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.
Conclusion:
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.
Literature:
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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