Can I ask your honest thoughts and feedback on GAMP?
The + and - of GAMP.
Do you like it, hate it, etc.
Thank you in advance.
Hi there,
GAMP, to me, is a perfect example of an attempt to define a
"one-size-fits-everyone" approach that fails to take into account the
reality of high-tech business, and hence is doomed to (at best)
insignificance or (at worst) active harm to the company. It has, IMO, cost
companies far more to implement that it has returned in either business
value or regulatory compliance value. In every GAMP environment in which I
have worked, significant man-hours are spent in generating paperwork that
(a) is never used by the business again, (b) imparts no useful information
and © is glossed over by auditors (internal and FDA) who accept the mere
presence of the document as evidence that the company is doing what it is
supposed to be doing, and who have no idea how to evaluate the actual
content of said document. And, in every GAMP environment in which I have
worked, people pay lip service to the concepts while realizing that the
constraints imposed by the methodology will keep them from getting anything
done in a time-efficient and cost-efficient manner. Meanwhile, the companies
that get things done do so by going back to the regulations and devising
methods for compliance that fit within their EXISTING “way of doing
business”. Some handful are even adopting versions of “agile” software
development approaches - all of which have the virtue of insisting upon
active stakeholder involvement from day one, which ensures that the system
never strays far from what the end users want - and devising ways to capture
adequate documentation to meet regulatory needs. I’m not aware of any such
company that has been cited by the FDA for having an indaequate process.
With all due respect, it’s about time we, as an industry, STOPPED trying to
develop “industry standards” that aren’t standard and “best practices” that
aren’t even very good. Every other high-tech industry has moved away from a
single “standard”, and realizes that the “best practices” come from within
the team doing the work, not from outside. GAMP might be better served to
help people understand the “intent” of the regulations rather than to
prescribe a particular set of “practices”.
My personal opinion on GAMP is mixed. As such I can give you both the pro’s and con’s as I see them
Pros: GAMP takes a step in the right direction to acknowledge the Validation Lifecycle element of project implementation. It provides a mechanism to standardize somewhat. I truly appreicate the idea that proper specification and control at the design phase can save headaches when qualifying the equipment.
Cons: I find GAMP 4 onerous to use at times as it tries to cover so much. It feels like rather than doing a few things well, it covers a lot just okay. The templates provided, which take up a large part of the book, I find to be disjoined and limited applicability. It feels a lot like the situation where you find a powerpoint presentation and have to try to piece together what the applicable parts are.
I acknowledge the presence of the good guidance practices and find the ones pertaining to electronic signatures/records and process control systems to be much more useful than the actual overall.
The one thing that I passionately feel about GAMP is that if it is to be accepted as a way of working that it should not be paid lip service to and then not carried out.
Why burden oneself with this approach if the steps to derive benefit from it won’t be carried out or carried out halfheartedly.
Cheers
GAMP is a very good guide to use as a tool to provide high level guidance to achieve validated and compliant automated systems. But like any other tool, you need to know how to use it. Unfortunately you cannot just pick up the guide and go to a system and validate it. One would need to know a few things in order to proceed. GAMP is a good roadmap for any automated system and it works for simple single process systems to highly complex and large DCS systems.
I use GAMP on all my projects. Many clients and their suppliers do not have a good level of knowledge of GAMP and I usually show them the benefits of using GAMP and they usually are very positive about that.