Case Studies

Case Study 1: Import and Qualified Person Release into Europe

A US client contacted Biotec regarding the import of an IMP into Europe for a clinical trial. The major issue being that the drug product had been manufactured in a facility that had subsequently been decommissioned and therefore the site was no longer available for audit. However, Biotec had already audited the current manufacturing facility. The client was working to tight timelines and needed to submit the IMPD as soon as possible.

Biotec are working closely with both the client, the MHRA and the QA department of the manufacturing facility to conduct a full review of the manufacturing process and documents. Upon satisfying himself that the manufacturing process complies with EU GMP, Biotec’s QP will supply the QP declaration required for the IMPD submission.

Case Study 2: Provision of Bespoke FDA / EU GMP Training

After working with a US client for several years and as part of the QP Consultancy service that Biotec offer, one of Biotec’s 5 QPs, Marc Weinzweig has been asked to make a bespoke presentation to the Company on EU GMP highlighting the differences between FDA and EU GMP regulations.

Case Study 3: Packaging and Labelling

A client made an urgent telephone call to Biotec on a Sunday afternoon requesting the packaging and delivery of one patient pack to a clinical site in Europe by the following morning.

Marc Weinzweig, the on-call Qualified Person recollects the events ‘I received a call on the Sunday afternoon requesting the urgent packaging and labelling of a patient kit that had to be delivered to the clinical site by the Monday morning. I immediately contacted the relevant members of my team who went to the Biotec facility to label, package the kit to ensure despatch on the Sunday night’.

The outcome was that the kit was received by the site on the Monday morning in time for patient administration.

Case Study 4: Design of a Shipping Configuration to Maintain a Temperature Range

Biotec were asked by a potential US client if we could design a shipping configuration that would maintain a temperature range of between -15°C and -35°C for a clinical trial to be conducted in South Africa.

Biotec successfully designed a shipping configuration, the shipments were made to South Africa with the temperature maintained within the specified range.