GMP News No. 353
13 October 2003
New PIC/S Guidance on Computer Validation
On 1 September 2003, the PIC/S document "PIC/S Guidance Good Practices for computerised systems in regulated 'GxP' environments" (www.picscheme.org) came into force.
The role of PIC/S is not clear to everybody. As the successor of PIC, PIC/S (Pharmaceutical Inspection Cooperation Scheme) is an association of inspectorates mostly - but not exclusively - from European countries (meanwhile also the US-American FDA has expressed its interest in a co-operation).
The document is primarily directed at the inspectors of the PIC/S member countries, to whom it is meant to provide guidance on how to conduct inspections of "computerised systems." It could thus be compared with FDA's "Guides for Inspection," which supply the inspectors with interpretations of the regulations concerning specific fields or questions. Although these documents have, of course, been written mainly for the inspectors, these interpretation aids are also very important for the pharmaceutical industry.
In January 2002, PIC/S published a draft document for commenting by the involved parties. These comments have been taken into consideration in the final version.
Just as the draft, the final version comprises 3 chapters: Preamble, Implementation of System, System Operation / Inspections / References. The subtopics, too, have more or less remained the same.
Part One Preamble
Part Two Implementation of System (draft titles in italics)
Part Three System Operation / Inspections / References
On the whole one can see that the document is strongly orientated towards the requirements of GAMP 4 (there have been controversial discussions on this - nonetheless positive - approach) and that many of the changes in comparison to the draft are due to the implementation of GAMP 4 requirements.
Here some of the changes compared with the draft document:
Reference to GDP (Good Distribution
The validation documentation must cover all
steps of the life cycle. The user has to be able to explain the
User requirements must be the basis for risk
Mention of a new document of the GAMP Forum
Special Interest Group (SIG) "Functional Risk Assessment." In this
document, special emphasis is placed on risk analysis.
The GAMP 4 software categories are taken over.
Retrospective validation: no alternative any
more for new systems. As for old systems, reference is made to an expected
GAMP Guidance "Legacy Systems." A system description, a test
against the specifications, and a risk analysis are required.
There have been many changes in the field of
"Electronic Records/ Electronic Signatures;" probably this was
partly in view of the FDA's changes in the 21 CFR Part 11 environment.
Furthermore, this document includes
comprehensive check lists and aide memoires, which can certainly be very
useful for every company in the preparation for an inspection.
Generally, one can say that this PIC/S document defines the state of affairs in the field of computer validation from the viewpoint of the supervisory authorities. Both the current developments concerning the industrial associations (GAMP 4 and Best Practice Guides) and the developments within the US-American supervisory authority FDA are taken into consideration.
Especially on this topic, we recommend you the following events: