Chromatography Forum

A while ago I posted on this topic but there was very little response.
There is a new standard: ASTM E2500
to quote from the reference below
This standard proposes the almost complete destruction of the validation “Vâ€

Hi Adrian,

This is a very important topic and I hope more members will comment on it. Until then, here are my comments.

Although I agree that equipment qualification is often overdone – mostly because of bureaucracy rather than comprehensive testing – I’m not completely convinced that plugging the instrument/s and running SST can be deemed adequate “qualificationâ€

My main point is to discover if anyone is implementing ASTM E2500, or will validation using the bureaucratic methods continue for many years to come.

I feel the old procedures give a false sense of security - it is vital to be aware of any changes in performance of the apparatus and not thinking,g because it is qualified all results will be OK.

Adrian

I tend to agree with your take on it. I think instrument qualification is one area that the FDA has highly overkilled. Not only does it often take a long time to get an instrument running. But you can walk into almost any pharmaceutical lab and find an instrument sitting in the corner, never used, covered with dust: that is state of the art but cannot be qualified for one reason or another. So I've seen many cases where best available technology is not used as a result of these requirements.

However, to my knowledge the ASTM standards are not all that relevant for Pharmaceutical/GMP type work. It is the guidance documents, the USP, and the CFR (and industry standard practise) the govern what we do. So I don't imagine this new ASTM standard will change anything.

Adam: The quote below from the reference in my first post indicates the ASTM standard is accepted by the FDA but who will be bold enough to change their ways?

So when will this happen? The answer to this is not clear. This standard has the support of the FDA, EMEA and GAMP so technically many sites could implement this process. However, although many Pharmaceutical engineers and companies have been talking about a different approach to validation, it will take someone to take the first step in using this standard. This new process will also have a large impact on company practices which are defined by policies, plans and procedures which will need to be updated. So we will all have to what and see who and how this standard will be interpreted and implemented by. In the meantime the validation “Vâ€

Adrian

I tend to agree with your take on it. I think instrument qualification is one area that the FDA has highly overkilled. Not only does it often take a long time to get an instrument running. But you can walk into almost any pharmaceutical lab and find an instrument sitting in the corner, never used, covered with dust: that is state of the art but cannot be qualified for one reason or another. So I've seen many cases where best available technology is not used as a result of these requirements.

However, to my knowledge the ASTM standards are not all that relevant for Pharmaceutical/GMP type work. It is the guidance documents, the USP, and the CFR (and industry standard practise) the govern what we do. So I don't imagine this new ASTM standard will change anything.

Agreed, as an analytical chemist working in the GLP environment, until the GLP guidelines reference these Standards, things are unlikely to change. The FDA and EMEA may support these documents but, until they incorporate them into their guidelines, the status quo will remain.