QP contract for CMO – Sterile and Non-sterile IMPs

A medium sized IMP drug product contract manufacturing organisation, based in the Midlands, required the services of an interim QP whilst recruiting and training a new permanent QP. The interim was required to support ongoing batch certification whilst a replacement was sought. JWQC had previously worked with the organisation so our reputation and experience in a wide range of dosage forms made us the ideal solution for their QP services.

The JWQC QP was able to:-

• provide a flexible onsite-at-short notice service due to the close proximity of the customers manufacturing site location.

• certify a range of sterile dosage forms (including biotech products) and non-sterile dosage forms.

• provide IMP QP consultancy services in parallel with certification services which identified areas of QMS improvement e.g. JWQC worked with site personnel to define improvements to the Product Specification File, a key document for QP reference and project management of IMPs.

The customer valued both the flexible approach and the recommendations for improvement that were made over the duration of the contract. Batch certification levels were maintained until a replacement permanent QP was recruited. JWQC were also able to educate staff on current expectations for IMP documentation, and this was shared throughout the organisation, benefitting their core business stream.

JWQC continue to enjoy a very good working relationship with the organisation and are frequently asked to provide ad hoc services as a result.