Interesting GAMP UK Meeting

As usual, last week's GAMP UK meeting (Help at Perkin Elmer) was informative and useful, especially in terms of the discussions that took place.

The formal agenda included a presentation on the use of Business Process Markup Notation (BPMN) for defining user requirements by Jenni Sanders (something we've been leveraging at Business & Decision for years) and a case study on the validation of a cell culture counter changed from non-GxP to GLP use, by Richie Fraser at Pfizer.

From a business perspective the most interesting session looked at the use of GAMP in the blood banking industry, with Janet Samson from Welsh Blood Service describing some of the cultural and organisational issues faced in the sector. In the last five years all blood banks in Europe now come under direct regulatory oversight but it is clearly a challenge to be part of a government led health service but regulated by a different part of the same government. With a number of projects in this sector this is no real surprise to everyone at Business & Decision , but it does prove that many of the real issues around validation are related to people and organisations, not technology.

There was also the usual regulatory round up with some feedback on the FDA's "Part 11 (Electronic Record, Electronic Signature) inspections, but to date it appears that the non-specialist inspectors who have been asking about the implementation of Part 11 have been learned more from the companies they have been inspected. There were however US and European based inspections and it would be interesting to hear how the 'overseas' portions of this program are progressing.

In areas of other regulatory news the tendency for the faster escalation of observations and the expectation to address any issues at all sites continues. It was also noted that there is a continued background of enforcement actions being taken around website content.

Chris Reid presented on the new Annex 11, but to be honest the experienced audience was generally aware of the new Annex 11 and the general feeling is that it will have minimal impact on those Life Sciences companies already following GAMP Good Practices (as we suggested in our "Annex 11, Changes to Computerised System Guidelines in the EU" webcast back in February). There was a feeling that some consultancies are over-inflating the issues associated with the new Annex 11, but our view continues to be that there are a significant number of companies who didn't comply with the old Annex 11 and that's where the trouble lies. The issue won't really be the new Annex 11 (which comes into effect in June 30th 2011) but the really issue will be the enforcement of Annex 11.

Matthew Theobald also presented on the work of the 'Leveraging Supplier Involvement' Special Interest Group and this was the topic that sparked the greatest debate. There is certainly growing regulatory interest in the outsourcing of IT services and regulatory concern when this is done badly. However, outsourcing can work an Matthew's group are trying to provide some good models on how the involvement of suppliers can be justified and how it can be done well.

A big thanks again to the GAMP UK organising committee for another interesting and successful meeting. For anyone who hasn't been to a GAMP meeting, it's well worth getting along to a meeting an finding out what really is happening in the industry - it's much better to the at the forefront of these trends that trying to play catch-up.