One of the greatest complaints about ISO standards is that, in the wrong hands, they can "certify" mediocre, or even poor business practices.
Allowing the industry to regulate itself probably won't work, as research has suggested. At this point, compliance is based on the "honor code" and pharma regulators must trust companies to audit suppliers and to implement quality systems.
ICH guidelines are voluntary, after all. There are a number of checkpoints in place such as cGMPs and GAMP. But, on a wider scale, how can a company prove that it is doing what it says it's doing as far as creating a continuous quality improvement culture is concerned?
John Walker, formerly the VP of quality and engineering with TechniKrom, is now working with Business Enterprise Mapping, and shared some of his thoughts in a brief interview recently. The company is doing some interesting work in helping companies visualize the road ahead to achieve continuous quality improvement in all their internal processes.
ISO is only a starting point, he said and gets companies to Level 3 (as defined by ISO...many pharma companies are probably around Level 1 or 2).
Eventually, the same auditors that do ISO inspections today might wind up doing the types of pharma inspections that could ensure ICH compliance.
So it was interesting to learn that the EC is suggesting third-party audits of API manufacturers. And to learn that one German company, BIB, has achieved top ratings for its independence, positioning it well for doing these types of audits in the future.
Will DNV et al move into this area as well? For more (from inpharmatechnologist.com), read on.
AMS
