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Case studies · Mid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur

Qualified Person (QP) and Head of Production provided

Following a personnel shortage, our appointed persons secured batch release and the QM system, and business operations continued without interruption.

How it went

Initial situation, procedure, result.

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

Topic areas

Medicinal Product Release Strategic GxP Consulting & QA Support Interim Management Operational QM/QA Support

Responsible for this case

Dr. Klaus-Peter Kreth Dr. Klaus-Peter Kreth Head of Production (AMWHV)

Initial situation

What the client came to us with.

A marketing authorisation holder/pharmaceutical entrepreneur required a Qualified Person (QP) to carry out batch release and to monitor and ensure compliance with the quality management system. The client also required advice on implementing quality assurance measures within the company. At times, a Head of Production was also required.

Procedure

What exactly we did.

Provision of a Qualified Person (QP) as well as a Head of Production. Strategic advice on implementing quality assurance measures and monitoring compliance with these measures.

Result

What came out of it in the end.

Successful continuation of the client's business operations, thereby securing the medicinal product supply through the manufacturer.

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