New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published

GMP News No. 559

GMP News
24 May 2005

 

New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published

 
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:
  

The international GMP Education Course "Successful HPLC Management in a GMP-/FDA-Regulated Environment and the ensuing Post-Conference Workshop on the Validation of Chromatographic Data Systems will provide you with more information on the contents and the advantages and disadvantages of the approaches described in the new GAMP Guide "Validation of Laboratory Computerized Systems". These events are held in Copenhagen from 21-23 September.

 
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG

  

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK