Blind Leading the Blind?

While attending a conference for medical product stability programs I was shocked to learn that several of my fellow stability managers from peer companies are planning to transition from a three-year chamber requalification schedule to five years. Some years ago, we were requalifying on an annual basis until we compared with others and switched to a three-year requal period. That switch was not without considerable concern from myself and management about the potential compliance risks. We were never questioned about the change in an audit, and our procedures had all been updated properly to cover it.

Now, however, I’m just not ready for the anxiety brought on by taking on this 5-year risk, though it does seem that several companies are on board with the practice. To sweeten the pot, since we have 37 chambers, we would save nearly $200,000 in those 5 years—not something to snub my nose at. The WHO Guideline Supplement 8 to Annex 9 (Temperature Mapping of Storage Areas) advises requalifying every 2 to 3 years, but while the WHO provides this specific timeline, the broader industry expectation is generally a risk-based approach that doesn’t seem to preclude others from doing an alternative and even our QA is on board. How can I make this decision either way and defend it—either to my boss for not saving the money or to an auditor for having such a long requal period?

Whatever you do, you need to have a validation master plan fully justifying your requalification period, whether one, three or five years. That justification will state why that period does not impose undue risk to product quality. Bottom line, the outcome of your argument for a 3-year or a 5-years plan will make the decision for you.