Reflecting on 21 years of GAMP

Last Tuesday saw the 21st anniversary celebrations of the GAMP Forum, now of course part of ISPE. It was a great opportunity to reflect on the history of GAMP and to catch up with some of the original founder members.

Although much of the talk was backward looking, rehashing events that led to the formation and subsequent growth of the GAMP forum, Randy Perez (current chairman of ISPE) did reflect upon the role that GAMP has played and continues to play within ISPE i.e. the GAMP Community of Practice has the best selling publications, the best attended conferences etc.

No one stopped at the time to really comment on why that might be. Having thought about it it occurs to me that this simply reflects the increasing importance of computerised systems not only in the pharmaceutical industry but also in everyday life. The pace of technology change is unending and it is perfectly understandable why GAMP came into being and why it continues to look into topical issues such as cloud computing, mobile platforms etc.

As long as this technology change continues apace GAMP will always have a role to play in applying well founded good practices to new technologies and new applications. There is however a significant challenge that ISPE/GAMP faces with the pace of technology change.

Looking back over recent years it appears that new technologies appear and are adopted by leading edge regulated companies faster than organisations such as ISPE/GAMP are currently able to respond. This is perfectly natural because the strength of organisation like ISPE and GAMP are that they are consensus driven and volunteer led. The time taken to achieve consensus and the limited time available from volunteers means that it takes months or years to discuss new technologies, the understand the implications, identify risks and how they can be mitigated and then to publish consensual good practice.

However, we're all aware that other technologies such as blogging, websites and social networking allow interaction between industry professionals in much shorter timescales. In many cases we are starting to see individuals and commercial organisations provide pragmatic and acceptable guidance well ahead of organisations such as GAMP/ISPE. The other part of the challenge is that although ISPE exists to serve the needs of the pharmaceutical community, the move towards greater outsourcing means that it is very often suppliers who are the subject matter experts with new technologies and consultants who have a broader experience in how new challenges are being tackled across the industry.

The challenge for ISPE and the GAMP Community of Practice is to get the balance right between achieving consensual good practices which regulatory agencies can buy in to and providing guidance in a timely manner. This will require more widespread use of some traditional channels such as ISPE Pharmaceutical Engineering and the greater use of Internet channels such as webcasts, web publishing and social networking. This will also mean continuing towards a model where suppliers and consultants provide valuable input but users from regulated companies are the final arbiters of what is acceptable with respect to good practice.

In some cases this will mean identifying a smaller number of thought leading subject matter experts and asking them to focus on providing pragmatic guidance in shorter timescales. This is certainly the way commercial organisations such as IVT and Concept Heidelberg are working when organizing conferences and commissioning articles and although ISPE/GAMP is a not-for-profit organisation it's important to realise that the lines between not-for-profit and commercial are indistinct in these areas. Another part of the challenge will be to identify appropriate subject matter experts in new technologies who may not be working in the pharmaceutical industry and who may not be part of the existing ISPE/GAMP community.

These challenges can however be overcome and ISPE is certainly moving towards this model, led as so often been the case by the GAMP Community of Practice.

Over the last 21 years GAMP has done an excellent job in providing practical guidance to the industry during what has certainly been the greatest period of technological change industry has seen. The fact that this has been led by volunteers (of whom both I, and Business and Decision Life Sciences are proud to be part) is perhaps one of the most amazing parts of the GAMP story. The fact that this extended community has developed good practices behind which most regulated companies and regulatory agencies now stand is a significant achievement and certainly one to be celebrated.

Happy 21st birthday GAMP - and here's to many more!