Annex 15 of the EU GMP guide is concerned with the
‘Qualification and Validation’ of pharmaceutical facilities, addressing
requirements for equipment, utilities and processes that are used for the manufacture
of medicinal products. The broad requirement of Annex 15 is that a pharma
manufacturer needs to identify what qualification and validation work is required;
next, the manufacturer must prove that critical aspects of work are controlled;
and finally, the key elements of qualification and validation need to be
defined and documented.
Validation and qualification form an important part of the
quality system in the pharmaceutical sector and can be defined in different
ways. Tim Sandle, Head of Microbiology, BPL, UK discusses some standard definitions
from a Good Manufacturing Practice (GMP) perspective.
The article has been published in the current edition of
Cleanroom Technology.
The reference is:
If you are interested in reading the article, please contact Tim Sandle
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources