Q3/2016 Our week with the FDA

For the first time in our history we supported one of our clients with the preparation for a GMP audit to be conducted by the FDA. Such an audit is something completely different as compared to similar audits by the Dutch Inspectorate. While the latter usually needs 1- 2 days for a GMP-audit done by 1 – 2 auditors, this time we were facing three USA-auditors during 5 days to assess compliance with their FDA regulations. But it worked out well and we received a VAI inspection classification which occurs when only objectionable conditions or practices are found that do not meet the threshold of regulatory significance. Inspections classified with VAI violations are typically more technical violations of the FDCA.

But we’re not only listening to “American rhapsodies” as this quarter also marked  the start of our African adventure. A leading  (South-)African radiopharmaceutical manufacturer asked for our help to upgrade their facility to EU GMP-standards and to prepare for EU marketing authorization applications as well. But since South Africa is a longstanding member of the Pharmaceutical Inspection Convention the essentials of modern Good Manufacturing Processes have already been introduced in this country long time ago. And that indeed was the result of our initial GMP-audit in this company. So the requested upgrade should not represent great difficulties.

The absence of such difficulties is not sure when it comes to the implementation of the EU Falsified Medicines Directive. To be more precise, we are then thinking about the practical implications of the so-called “serialization” which requires a unique code on every individual patient pack of a medicine. This should be in place by February 9 2019. Quite a lot of additional work (databasing) then will be necessary both at a pharmacy level as well as at the manufacturing level. But the real problems may emerge at the wholesale level as wholesalers have the obligation to verify the right status of their received shipments. Can you imagine them unpacking each and every pallet to scan all patient packs individually?