Case studies · Large international pharmaceutical company

Method transfer and EU retesting for launch from a third country

Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.

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

Medicinal Product Release Analytical Services Operational QM/QA Support

Responsible for this case

Dr. Thomas Lutz Qualified Person (QP) under § 14 AMG

Dr. Olaf Mundszinger Qualified Person (QP) under § 14 AMG

Initial situation

What the client came to us with.

A marketing authorisation holder was planning the launch of a medicinal product manufactured in a non-EU country and required a laboratory for EU retesting, a warehouse for physical import, storage and distribution, as well as a partner for batch release following import. The manufacturers also needed to be qualified. Preparation of PQRs for the ongoing monitoring of product quality was also to be carried out by the partner.

Procedure

What exactly we did.

Implementation of the analytical methods in A&O Pharma's laboratory (analytical method transfer), as well as EU retesting in A&O Pharma's laboratory. Import and warehousing together with a logistics partner. Oversight of the GMP-compliant manufacture of authorised medicinal products with batch release. Conducting audits to qualify the contract manufacturers. Preparation of PQRs for ongoing monitoring of product quality.

Result