Case studies · Mid-sized company, marketing authorisation holder

Manufacturing site transfer: CMC review, transfer plan and support

Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufacturer.

Discuss similar case Regulatory Affairs

How it went

Initial situation, procedure, result.

Without embellishment and in the order in which it actually happened.

Topic areas

Regulatory Affairs Strategic GxP Consulting & QA Support

Responsible for this case

Dr. Emmanuel Bey Development Analytics

Ute Hegener Regulatory Affairs

Dr. Barbara Siebertz Regulatory Affairs

Initial situation

What the client came to us with.

A mid-sized pharmaceutical company required regulatory and QA support as part of a planned manufacturing site transfer. In a first step, the current CMC documentation, including the relevant parts of Module 3, was reviewed. In a second step, the manufacturing site transfer was supported strategically and operationally.

Procedure

What exactly we did.

Review and assessment of the marketing authorisation chapters, review of the quality-relevant documents, preparation of a transfer plan including relevant risk assessments, support of the transfer including preparation of the documents and risk assessments.

Result

What came out of it in the end.

The results of the reviews were presented to the client and recommendations were given for selecting a contract manufacturer. Once the client has made this decision, the transfer process will be started.

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