Article of the month April 08 - GAMP 5 - Innovation in a Flexible Manner

GAMP 5 - Innovation in a Flexible Manner

Brought to you by Bharat Nijon

The new GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems provides a practical approach to achieving systems that are fit for their intended use in an efficient and highly effective manner, while also enabling advancement in technology and innovation. The improved GAMP guide offers a more flexible risk based approach to compliant GxP systems based on scaleable specifications and verification. This approach relies heavily on having a robust quality risk management system. GAMP 5 also contains interesting information on out-sourcing electronic batch records and smaller spreadsheet and database applications.

Please leave comments about this article in this thread


It is well worth remembering that all the GAMP issues have been, and still are, purely advisory documents. I have never seen a 486 that even mentions them.

If a company is compliant with its regulatory requirements, it will have written its own equivalent of the GAMP-1/2/3/4/5 series. Only difference is it will have titled it company Regulatory Practices and Procedures (RPP) (or something similar), and they will be specific to the company.

All the GAMP series of documents have been authored by committees, and not everybody in a committee can get their own say. So often there is contentious material included in the final issue.

GMP’s should be closely studied and the requirements, as applicable to your company’s activities, should be extrapolated and developed into your own Regulatory Practices and Procedures manual. This manual must then become the definitive authority on all company quality and validation matters.

GAMP has tried to be all things to all people and in the opinion of many fails to be specific enough to be used as anything other than a discussion document. Where as, the work put in to developing your own RPP, will pay endless dividends, since it will detail and document the individual responsibilities of all personnel involved. It will also define the scope and methods to be used, along with establishing standard templates for all regulatory required documents.

In short it becomes the method statement for all quality and validation tasks. It ensures all protocols are in place and ensures that the scope of each document is appropriate to its title. It further ensures that tasks and projects are initiated with approved URS documents, and that each subsequent document is correctly scoped.

Ensuring each person in the chain knows what to do, and has a documented method statement to follow, is the only acceptable method in the aviation industry and it must become so in the GMP regulated industries.

Alex Kennedy