“The effectiveness of the arrangements for product recall should be evaluated regularly (at least annually)” Clause 6.5 – Guidelines on Good Distribution Practice of medicinal products for human use (2013/ 343/01)
That’s what it says. A simple sentence. A straight forward instruction that, in the absence of a genuine recall, the process is proven to work. A test of traceability. I have, of course, isolated it (the first sentence) from the rest of the clause, but is still a surprise how it can strike trepidation in people – even if it is recognised as an important task. Is it the fear of data-gathering? Or of the transparency of time-lapses? Perhaps an exposure to holes in procedures? If so, let’s try to consider it is a positive exercise.
Procedures can have holes- let’s face it. The Dummy or Mock Recall can easily flash these up. Warehouse Management Systems can be found to not have a search-by-batch feature. Can parcels containing that product and batch be easily retrieved? If not, what communication lines are in place to arrange their return? Can the storage locations be quickly identified and the stock placed into Quarantine, both physically and theoretically?
Experience tells us that the Dummy or Mock Recall provides opportunities to not only ensure relevant procedures are water-tight when the real thing happens – but whether the processes in place can be trimmed down for further efficiency or beefed up for full accountability. Don’t recoil from the recall.
Written by Brian Lindsay