Facilitating a Successful Acquisition 

A Sponsor approached JWQC to request a vendor audit following a positive referral from a CMC consultant. Following the audit, and having experienced the JWQC approach to vendor qualification, they continued to request support for their GMP oversight activities on an ad hoc basis. Over time they understood the benefit of the JWQC systems, and started using them to organise their work.

JWQC systems provided:

• a document register to  manage and monitor documentation required

• a risk register to monitor concerns and uncertainties that required resolution

• support and facilitation for GMP Sponsor oversight activities using JWQC systems

• an organised Quality Drive structure which allowed for clear visibility and easy retrieval of all documents during acquisition due diligence activities

When the Sponsor was subsequently acquired by a large pharmaceutical organisation, the JWQC systems  ensured a straightforward  transfer of documentation, including product knowledge through technical reference file indices, vendor status through vendor qualification documents and inventory through Quality Assurance Statement with associated CMO certifications.   

The large pharma organisation were confident to release the Sponsors product based on the documentation provided by JWQC.