Multiple CMO audits for IMP Manufacture – US-based Sponsor

A US-based sponsor required a series of audits to qualify their UK based contract manufacturing partners for their Investigational Medicinal Products. The company had prior experience of JWQC audit services as we had conducted an audit of their active pharmaceutical ingredient CMO.

In-depth experience of EU GMP was needed as the IMP was to be released for clinical trial in the EU. A Qualified Person audit was preferred in order to ensure acceptance of the audit by the QP releasing IMP to clinical trial.

JWQC fulfilled the sponsor’s requirements:-

• Audits of the GMP manufacturing supply chain were conducted by QPs, specialists in the manufacture of Investigational Medicinal Products and experienced in the dosage form

• Two QPs were provided where necessary to reduce the amount of time required on the auditee’s site but to enable fulfilment of the audit purpose and scope

• The audit programme was managed by JWQC, and included monitoring and assessment of responses and issuance of audit close out certificates to the US sponsor

• Audit scope included manufacture of API and Drug Product, Quality Control testing, Clinical Trial Packaging & Labelling, QP Certification, Release & Distribution to trial

• In addition, JWQC managed the need for a number of GCP/GLP audits.

By outsourcing the audits to JWQC the US-sponsor received a comprehensive set of audit reports, a list of findings, an assessment on how the findings and the auditee’s response may impact the manufacture of their drug product project and advice on how any shortfalls could be mitigated. The US-based sponsor could be confident that our EU-based auditors had the right experience to be able to check CMO compliance against EU GMP.