JWQC had been working with a Sponsor organisation over several years, qualifying the CMO’s in their supply chain. During this time JWQC Quality Management Systems had been employed to provide the means of conducting GMP oversight in a consistent way, to evidence the sponsor’s GMP responsibilities.

By utilising JWQC experience and systems, the Sponsor acquired knowledge about GMP requirements and responsibilities that they had previously been unaware of, and they recognised the benefit of having systems in-house for Sponsor GMP oversight.

Working with the sponsor, we provided awareness of the benefits of conducting the procedures as designed, and adapted them to fit in with the sponsor’s ways of working. We ensured a successful transfer of our processes to the sponsor’s Quality Management System.

The Sponsor did not have the GMP knowledge but JWQC provided this, facilitated by regular meetings at which both known risks and potential hazards at CMOs were discussed. These included:

• potential cross contamination risks at the CMO that were apparent to JWQC but not to the CMO or Sponsor

• risks highlighted at the CMO that demonstrated that they were not as GMP compliant as originally thought e.g. lack of QC identification testing conducted on outsourced printed clinical labels

JWQC’s help with implementing a QMS system that is tailored for Sponsor oversight, along with regular meetings and mentoring in GMP, has allowed this organisation to move towards drug commercialization knowing that potential risks to their product are now being highlighted and controlled.