Case studies · Mid-sized contract manufacturer of medicinal products
QP batch release after EU import for a Swiss contract manufacturer
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing basis and advise on changes and quality management.
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
Topic areas
Responsible for this case
Dr. Klaus-Peter Kreth
Qualified Person (QP) under § 14 AMG
Dr. Emmanuel Bey
Qualified Person (QP) under § 14 AMG
Dr. Barbara Siebertz
Information Officer under § 74a AMG
Ute Hegener
Information Officer under § 74a AMG
Anonymised. Confidentiality is part of our business; we only name clients with their consent.
Starting point
What the client came to us with.
It also needed regulatory support on changes to the manufacture and analytical testing of the medicinal products, as well as support with operational QM tasks.
Approach
What we actually did.
We assess planned changes and advise on them. We also provide operational support to maintain GMP compliance.
Outcome
The outcome.
In a similar situation?
Speak directly with Dr. Klaus-Peter Kreth.
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