[Ed Groleau]

Reply To: Regulatory release of IMP

All QA units I have worked with have been responsible for all aspects of release. That means they confirm that the clinical kits meet all GMP requirements from drug substance through final package, meet the clinical requirements for supplying the trial, and meet the regulatory requirements for the country of release. This may happen in multiple stages. Approval of the CoC can document approval of the GMP activities and country releases may happen later as regulatory approvals occur but the Quality Unit is responsible for doing all of that. I have seen additional reviews of batch records for technical purposes but these are in addition to the QA review and approval.

Communication of regulatory releases can happen through various routes. Typically the CRO is the conduit with the local agency who passes the CTA approval to the sponsor’s clinical contact who then disseminates as needed. My experience is that the notice of country approval includes the QA Unit as the ultimate responsibility for release rested with them. I suppose in theory QA could complete the GMP release only as long as a process is established that prevents distribution of the material until regulatory approval has been received but none of the QA groups I have worked with are willing to take that risk. My QA have always been responsible for both the GMP and regulatory release.

There are various ways I’ve seen to document the approvals from forms to systems. The IRT can require multiple people to acknowledge information to complete a release, one of whom may be a QA role. Or a form needs to be approved by the person doing the IRT release confirming that approval from the specific country has been received.

QP release, where required, is a local requirement and additional to the QA release. QA must complete their release before the QP review is started.