The
GAMP Forum has published the new GAMP Good Practice Guide "Validation of
Laboratory Computerized Systems". This document, which has been
designed especially for computerised systems in analytical laboratories
(in a GMP-, GLP- or GCP-regulated environment), is a complement to the GAMP 4 "Guide for Validation of Automated Systems".
This additional guide takes the fact into account that there are very
different devices in a typical laboratory and that it is thus neither
feasible nor cost-conscious to fix the same procedure for the validation
of the systems of all present lab devices.The
recommendations given in this guide are meant to help the user in the
pharmaceutical industry to develop a rationale for a graded scope of the
validation of computerised systems in the lab. One important tool for
establishing the scope of validation are risk management considerations.
The following considerations have to be taken into account during risk
analysis:
- Will a potential mistake have grave consequences?
- How likely is the occurrence of this mistake?
- How good are the chances for the potential mistake to be discovered
in time?
However, the central point of this new guideline is the new
classification into seven categories (A through G). Especially for the
laboratory, the former five GAMP categories have been subdivided further.
Category A represents systems whose software cannot be configured or
modified (ovens and centrifuges are mentioned as examples), and category G
stands for complex systems (example: self-programmed software or modified
spreadsheets).
The practical implementation still has to show
whether this further subdivision is really helpful. The authors themselves
state that e.g. a NIR spectrometer can be classified as C, D or E -
depending on the technical complexity of the system.
There is certainly some truth in the document's statement that many
analytical systems are commercially available systems for which the System Implementation Life Cycle
(SILC) described in the GAMP Guide is suitable rather than the traditional
System
Development Life Cycle (SDLC).
As to the wording, the authors of the new GAMP Guide
have again chosen the term "validation" instead of
"qualification", since "validation" is considered to
be the more comprehensive and therefore more suitable term.
You can order the GAMP Good Practice Guide "Validation of
Computerised Analytical Systems" if you click here.
Learn more about the new GAMP Good Practice Guide:
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