The Qualified Person, known in Germany as the Sachkundige Person, is the person who checks and releases every batch of a medicinal product before it is placed on the market. Without their certification, no medicine may be sold in the EU. Anyone who has products manufactured by a contract filler must therefore clarify who takes over batch release and which tests are required for it. This article explains the role, responsibility and procedure.
Key takeaways
- The Qualified Person personally certifies every batch and is liable for this decision.
- For manufacture outside the EU, release is carried out by a QP in the EU, usually after a control analysis in the importing country.
- Lubeca fill provides the complete batch documentation that the client’s QP needs for release.
What is a Qualified Person?
The role of the Qualified Person is laid down in Directive 2001/83/EC and implemented in Germany in the Medicinal Products Act. Every manufacturer and every importer of medicinal products must name at least one QP. A QP needs a degree in pharmacy, medicine, chemistry or a related subject and several years of practical experience in quality control. The authority verifies the qualification and lists the person in the manufacturing authorisation.
What are the QP’s tasks in batch release?
Before release, the QP checks whether the batch was manufactured in accordance with GMP and the marketing authorisation. The QP reviews the batch documentation, assesses deviations, checks the analytical results and ensures that all validations and qualifications are valid. Only then does the QP certify the batch in a register. This signature is a personal decision that cannot be delegated.
Batch release when a contract filler manufactures
| Scenario | Who releases? | Special feature |
|---|---|---|
| Contract filler in the EU | QP of the contract filler or QP of the client, depending on the contract | Responsibility is defined in the quality agreement |
| Contract filler outside the EU | QP of the importer in the EU | Every batch undergoes a control analysis in the EU unless a mutual recognition agreement exists |
| Country with a mutual recognition agreement | QP of the importer in the EU | Control analysis can be waived, release based on documentation |
There is currently no mutual recognition agreement between Turkey and the EU. Batches filled there therefore undergo a control analysis in the EU on import before the importer’s QP releases them. This step should be taken into account in the schedule and the costing.
Which documents does the QP need from the contract filler?
- Complete batch record with all process parameters
- Certificate of analysis for the batch
- Results of sterility test, endotoxin test and particle inspection
- Environmental monitoring during filling
- List and assessment of all deviations
- Evidence of the use of released starting materials and packaging materials
- Confirmation that validation and media fill are valid
How is the cooperation regulated contractually?
Annex 16 of the EU GMP guide describes how a QP may rely on tests performed at other sites. The prerequisites are a written agreement, an audit of the site and a functioning quality system. The quality agreement between client and contract filler therefore defines which tests take place where, how deviations are reported and in what form the documentation is handed over.
Batch documentation at Lubeca fill
Lubeca fill was founded in 2019 and fills sterile liquids into ampoules, vials and bottles in Çorlu near Istanbul. Every batch is fully documented, from line clearance to packaging, and handed over to the client together with the results of the in-process controls. EU GMP certification is currently in preparation. How an audit works with us is described in the article on GMP audits. The role of process simulation is explained in the article on media fills.
Frequently asked questions about the Qualified Person
Can the contract filler take over the release?
Within the EU yes, if it has its own QP and this is agreed contractually. For sites outside the EU, a QP of the importer always releases.
What happens in the event of a deviation?
The QP assesses whether the deviation affects quality. The QP can release the batch, reject it or order further tests.
How long does batch release take?
Depending on the scope of testing, a few days to a few weeks. The sterility test with 14 days of incubation usually determines the duration.
Would you like to know how batch release works with Lubeca fill? Contact us.
