QP needed urgently – IMP secondary packaging

A large global pharmaceutical organisation, with a clinical trial secondary packaging site based in the UK, required the services of an interim IMP QP. The organisation was unexpectedly left short of QPs due to recruitment issues. JWQC was recommended to the customer by another contract QP organisation who was known to both parties.

JWQC, having extensive experience in the manufacture and packaging of a range of IMP dosage forms, was the ideal solution for the customer. JWQC was able to provide interim QP cover, bespoke to the customers’ needs, at short notice.

The QP:

• quickly got to know the customers PQS, personnel and facilities, spending three days per week based at their manufacturing site.

• became integral to project meetings and provided valued input and expert QP guidance on investigations and PQS improvements.

• performed routine and regular batch certification of IMP destined for global distribution.

• certified a range of dosage forms, including imported product, in addition to product manufactured in the EU/UK.

The valued contribution of JWQC led to the GMP consultancy and batch certification services continuing for a period of 18 months. Changes to their warehouse operating systems, implemented as a direct result of JWQC advice also saved the company thousands of pounds in energy bills – an additional welcomed benefit to the organisation!