Case studies · Medium-sized company. Contract manufacturer of medicinal products

Batch release after EU import for a Swiss contract manufacturer

Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.

Discuss similar case Medicinal Product Release

How it went

Initial situation, procedure, result.

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

Topic areas

Regulatory Affairs Medicinal Product Release Strategic GxP Consulting & QA Support Operational QM/QA Support

Responsible for this case

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

Dr. Emmanuel Bey Development Analytics

Dr. Barbara Siebertz Regulatory Affairs

Ute Hegener Regulatory Affairs

Initial situation

What the client came to us with.

A contract manufacturer of medicinal products based in Switzerland required a partner for batch release of commercial, authorised medicinal products following import into the EU. The contract manufacturer also required regulatory support on questions relating to changes to manufacture and analytics of the medicinal products, as well as support with operational QM tasks.

Procedure

What exactly we did.

Oversight of the GMP-compliant manufacture of authorised medicinal products with batch release following import into the EU. Assessment of and advice on planned changes, and operational support to maintain GMP compliance.

Result

What came out of it in the end.

Continuous batch release of authorised medicinal products and assurance of medicinal product supply. Compliance with regulatory and GMP requirements in medicinal product manufacture.

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