The first comments on GAMP 5 are indicating that the original heavy handed approach to document design has been reviewed and a somewhat more pragmatic attitude now prevails. Those who have tried to use GAMP 4 as a template, or as a base for constructing compliance documents quickly find out, that there quite a few contradictory requirements, and an awful amount of complication. Is it an attempt to catch all, in one document?
We at Validation Online are very pleased that GAMP 5, is recommending practices that we have advocated for several years (not all, but several). Read through our thoughts and recommendations on Computer validation, this is almost identical to the GAMP 5 philosophy. Read through our thoughts and recommendations for Risk Assessments, again this is in line with the current thinking. These recommendations were published on the Validation Online website between two and five years ago, and represent the collective thinking of our regulatory compliance authors.
The treatment of software mirrors our own recommendations. We have always advocated that there was no point in reviewing code for a standard PLC type installation, as long as the risk assessment judged that all the functionality of the code could be functionality tested. Some of us here originate from software and system aviation design, in that capacity we used very sophisticated Risk Assessment Programs (RAP), in fact many RAP’s you see today originated in the aviation industry. It completely confounds us why these systems are being advocated and used to judge the degree of validation that a piece of equipment used in the pharma industry should be subjected to, when this is such a relatively simple judgement.
There really is only four grades for validation;
- Validate or not validate.
- Full life cycle validation.
- Standard Validation.
- Simply Validation (Calibration and registration).
To use FMEA to verify this is really anything but cost effective.
Why does this body bring out a document that is not easily accessible by the persons they are purported to be targeting it at, is very expensive, and encrypted to such an extent that the end user cannot use any of the documents as templates.
Had this guide been brought out at a much reduced price and downloadable format, most persons in the industry would have bought their own copy. Instead, I think they have gone straight to the point of diminishing return. Would we recommend it? Our collective opinion is no.