|
After PIC/S published the draft of this recommendation for commenting by
the industry last year (GMP
News of 12 September 2001), the final version was published on 24 June
2002. The recommendation came into force on 1 July 2002.
Like all PIC/S documents, this document, too, addresses inspectors of
supervisory authorities. However, since it reflects the state of the art
and as it shows which questions might arise in future inspections, it is
also of great interest to the pharmaceutical industry.
The history of the document was discussed in the GMP
News of 12 September 2001. In comparison to the draft, the general
structure of the document has not changed (8 chapters with basic
requirements on 6 pages; a 14-page-long appendix with detailed
information). Some of the chapters have been modified or expanded. In the
following we have listed the most important differences between the draft
and the final version:
- The final version gives more details regarding the requirements on
isolators for sterility testing; whereas isolators used for production
have to be located in a class-D cleanroom, those used for sterility
testing only have to be placed in a controlled, but not necessarily
classified room
- The expression "sporicidal process" and the requirements
that result from it are mentioned more often; a six-log reduction is
not defined, but is considered to be the state of the art
- More emphasis is placed on maintenance (maintenance program), among
others for gloves and gas generators
- The sterilisation of the cooling zone at the end of a hot-air
sterilisation tunnel is considered to be critical
A program to minimise
the risk of loss of integrity of gloves, sleeves and suits is required
A minimum of 10 Pascal
positive differential air
pressure is recommended in contrast to the draft (15 Pascal)
The material to be sterilised should be identified, and the
rationale used should be documented
After testing the HEPA filters with dispersed oil, the first gassing
should be considered as neutralising operation
If studies have been carried to show that the lethality of the
bioindicators on the carrier material is approximately as high as the
lethality on the material to be sterilised, no in-house studies have
to be conducted
Generally speaking, the requirements on the use of bioindicators is
described in more detail than in the draft
ECA organises the following events in this field/context:
The recommendation can be downloaded via the following
link.
Author:
Dr Andreas Mangel
CONCEPT HEIDELBERG
|
