At the beginning of 1996 the document PH 1/96 "Principles
of Qualification and Validation in Pharmaceutical Manufacture" was
published by the
Pharmaceutical Inspection Convention (PIC). This document has been the
first to give definitions in the field of production on the topics:
- Validation Master Plan
- Installation and Operational Qualification
- Non-sterile Process Validation
- Cleaning Validation
that were mandatory for the PIC member states.
This document was "put to the
test" for two years and then revised according to the experience
gathered during the "test phase" and the commentaries by
industry and authorities. The revised version came into force on 1 March
1999 under the title PIC/S PR 1/99-1. A revision of the PIC/S document PR
1/99-2 followed, which was mandatory from April 2000. This revision
encompassed only the insertion of a copyright note, an alteration in the
e-mail address of the editor, and a new page numbering.
PIC/S PR 1/99 was the basis for Annex 15, which came into force in
September 2001.
In autumn last year the PIC/S document PR 1/99-2 was revised again. It
was part of the revision that the document was given the new number PI
006-1. This was due to the fact that the PIC/S committee had adopted this
document as a "Guidance Document" for inspectors.
What else was changed?
Again, the editor's contact address was altered (new e-mail
and internet address).
The latest changes were included in the document history.
Since the introduction had been modified, both the numbering of the
chapters and the page numbering changed.
What has now changed in the introduction?
The text points out that the basic principles of the topic
qualification/validation are described in Annex 15.
The document serves as a guideline for the inspectors, but is now also
used in the education of inspectors and considered as a helpful tool for
the preparation of inspections.
Particular emphasis is given to the fact that on the one hand the
document is not mandatory for industry, but on the other hand "industry should consider these
recommendations as
appropriate." Besides, the text stresses that the document reflects
the state of the art.
Which changes do now result from the revision for the practical work?
On the whole the influence is small. However, the document's importance
has grown considerably due to the new introduction. Especially since many people
interested in validation/qualification were disappointed by the contents
of Annex 15 because they had expected to get more concrete information.
This is why more often again those seeking advice consult the document
(that is now titled) PIC/S PI 006-1.
It is surprising that the revision was not better harmonised with the
Annex 15. Thus there are still differences between Annex 15 and PIC/S PI
006-1 as regards the definitions of the Performance Qualification (PC).
Both texts document the state of the art, in this respect both approaches
are practicable and therefore one of them should be selected according to
the individual validation project. Another discrepancy lies in the fact
that PIC/S PI 006-1 does not contain the requirement of a risk analysis as
included in Annex 15.
This means that some questions about how to put the two
regulations into the practice of validation and qualification activities
remain unanswered.
The following ECA Education Course will
help you to find the answers:
This event is recognised within the
framework of the ECA Professional Certification Programme. Please
click here if you would like to read more about it.
Writer:
Sven Pommeranz
CONCEPT HEIDELBERG
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