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Setting up a QP batch release system

QP Batch release system

Before an organisation can bring a batch of a (bio)pharmaceutical product, e.g. a vaccine or blood product, onto the market, it must be extensively tested and, for the EU QP (Qualified Person) release is mandatory. PME-Progress can manage this process.

Setting up a QP batch release system for a new product
A challenging task for Progress-PME was setting up a QP batch release system for a new product of a CMO (Contract Manufacturing Organisation). Before the product can be released, the batch manufacturing records and the release tests must be extensively reviewed by a QP.
In this case, the product was a sterile injection preparation for a multinational pharmaceutical firm specialised in urological and oncological products. The company concerned had been awarded the rights for a new sterile oncological product produced by a CMO in the US. Part of this change was transferring responsibility for the QP batch release from a German CMO to the relevant production location in the US.
Progress-PME was contracted to initiate and implement the batch release, ahead of the arrival of a new Qualified Person for this product.

Close partnership
We started by establishing a close partnership between the contract manufacturer in the US, the contract batch release site and the Quality Control contract labs responsible for implementing the EU release tests for the product. We set up a meticulous QP batch review system to be able to perform a detailed check of the batch production records and the required QC/EU test protocols, including a regulatory compliance check. At the same time, we ensured that supporting quality systems, such as the handling of deviations and managing changes and complaints, were implemented.

The close cooperation between the Registration and Supply chain departments ensured that product changes submitted during the project were relatively easily implemented. We regularly visited the contract manufacturer in the US and the labs in Germany for project meetings as well as during supplier inspections.

The greatest challenge in this project was setting up a new QP release system that had to run parallel with the ongoing release of  productbatches for the market. This was successful. There was a gradual transition from the former batch release site to the new batch release site in the Netherlands.

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