I'd be a little surprised if many people have experience with ASTM E2500, E2537, and other proposed ASTM E55 committee specifications, as they are still very much a work in progress.
I'm not too familiar with the ASTM programme, but they complement the ICH Q8 ( Pharmaceutical Development ) and Q9 ( Quality Risk Management ) documents released in the last few years, which themselves point more towards the risk management approach of the ISO Quality Systems.
Their introduction is rather slow, possibly because current quality groups don't have appropriate skills.
The main feature of all of these quality systems is the introduction of a risk assessment into the process, with regard to product performance, quality, and patient safety. The scope of work required to meet those goals is then agreed and implemented.
How much effect these will have on laboratory quality systems is yet to be seen, but hopefully they will continue to move towards the ISO 17025 model for testing laboratories.
17025 is based on the ISO 9000 continuous improvement, risk assessing, quality system model with the additional inclusion/recognition of "competence", providing somewhat more flexibility for analytical laboratories - as "competent" technical people can perform/document simple risk assessments, and decide what is required.
The FDA has been much more interested in risk-assessing quality systems over the last couple of years, since they were required to review the effectiveness of their traditional prescriptive systems.
Unfortunately, whilst 17025 accreditation is the recognition of competence to make decisions and report results, the audit/approval system used is national, making most pharmaceutical regulators somewhat wary of it's role in the global market.
I also can't see pedantic quality critters changing spots easily, and may struggle with the analytical skills needed for risk-assessing quality systems.
Please keep having fun,
Bruce Hamilton
