IMP Co-Ordination & QP

The CBF has a dedicated team that is responsible for the project administration, co-ordination, and management of vaccines and associated paperwork. In addition, the team works closely with, and supports, the Qualified Persons with importation, labelling, distribution and release of vaccines for clinical trials in accordance with the current legal requirements.  An individual manufactured batch is often used in multiple clinical trials. Release of a batch to an individual clinical trial and associated labelling(s) are separate activities (each labelling and release to a specific trial requires trial-specific certification).

Released IMPs are stored in a dedicated -80°C freezer or dedicated sealed containers at +2 to + 8°C under the control of the GMP/GCP Project Manager and QA team. IMP storage areas are temperature monitored and -80°C freezers have CO₂ back-up in the event of a freezer fault. Quarantined products are similarly segregated. All other IMPs (rejects, samples, returns) are stored in dedicated storage locations at the appropriate temperature.

New requests to supply IMPs are handled directly by the GMP/GCP Project Manager, who is responsible for packaging and shipping according to a standard procedure. The team ensures the CBF maintains compliance with evolving current legislation in IMP storage and Good Distribution Practice (GDP).  The team also manages the inventory of IMPs ensuring records always reflect current stocks, and that temperature monitoring of storage areas is undertaken.  QP retention samples following secondary labelling to clinical trial are stored separately by the GMP/GCP Project Manager.

In addition to manufacturing and releasing dosage forms manufactured on-site at the CBF, the team also undertakes significant secondary packaging and labelling of IMPs, as well as marketed products that are being studied as an IMP for use in a variety of clinical trials.

IMPs are only shipped to clinical trial sites following clinical trial specific labelling and QP certification. Final QP Certification to trial will only occur after all the batch certification steps have been met and the batch has been confirmed to meet the requirements of the Product Specification File and Clinical Trials Application (CTA). Released Product is dispatched to a pharmacy or clinical trials unit only.

QP

The CBF currently has three QPs named on the Manufacturing License. All QPs meet the qualification requirements of Articles 49 and 50 of Directive 2001/83/EC. Overall, the CBF has supported nearly 100 clinical trials by labelling, certification, QP importation and providing products.

The QPs at the CBF have the following responsibilities:

• Ensure GMP Compliance and Certification of batches of IMPs manufactured by the CBF.
• Provide Final Certification for product use in specific clinical trials for products manufactured by the CBF and other contract manufacturing organisations (CMOs).
• Provide QP declarations of product suitability if manufactured outside of the EU[CO1] .
• Auditing of critical suppliers and contract testing organisations, including CMOs where the CBF is taking on QP responsibilities for importation or release to clinical trials.
• Maintain awareness of the legal responsibilities of the QP within in the pharmaceutical industry.
• Provide support to the all members of the Quality team.
• Provide expert advice to all members of the CBF and Sponsors on GMP manufacturing and testing and basic regulatory requirements.