Providing analytical and quality assurance services for the entry of imported pharmaceutical products into the European Union market. Quality assurance of the entire pharmaceutical supply chain from the manufacturer of the active ingredient to the EU receiving warehouse of the finished product.
Our services:
Our company is licensed for the testing and release of pharmaceutical products in accordance with EMA Directive 2001/83/EC. At the customer's request, our own Qualified Persons (QPs) can certify batch release testing in accordance with Annex 16 of the EU GMP Directives.
Clients who wish to import medicines into the EU can also rely on our services.
- QP/API declaration
- Batch Release Certification
- Storage of reference/retain samples
Main milestones in the EU release process of imported pharmaceutical finished products
Issuing of the API declaration:
To submit Eurofins Analytical Services Hungary Kft. to the Marketing Authorization as EU batch release site, the active substance (API) needs to be declared by a Qualified Person proving that it is manufactured in compliance with the detailed guidelines related to the good manufacturing practice for starting materials. As a first step a CDA/NDA should be signed and the cooperation should be based on an audit QA agreement.
contact: bru@laboratorium.hu
Analytical Method Transfer, verification of the Pharmacopoeia methods
Validated analytical methods should be transferred (collaborative or direct transfer) from the sending unit (typically the QC laboratory of the finished product manufacturing (FPM) site) to our laboratory (receiving site).
Analytical method transfer (AMT) activity should be carried out according to preliminarily approved AMT protocol and results should be documented in the AMT report.
The analytical methods used at FPM site should be in full compliance with Marketing Authorization (MA) CTD module 3.2.P.5.2. Each modification in the analytical methods during the AMT should be registered in the MA.
Pharmacopoeia methods (e.g. MLT, sterility, BET, KF titration, osmolality etc.) should be verified in the receiving laboratory.
contact: pharma@laboratorium.hu
Signature of the Quality Technical Agreement (QTA)
Trilateral quality agreement between the marketing authorization holder (MAH), the manufacturer of the pharmaceutical product and Eurofins (as European batch release site) should be signed prior the collaboration begins to define the duties and responsibilities between the parties regarding the supply chain.
contact: bru@laboratorium.hu
Evaluation of the Compliance dossier:
The Compliance dossier contains the product specific documents (such as manufacturing process, process validations, testing specifications and methods, manufacturing licenses and audit reports, Marketing Authorization, etc.) which are necessary to be assessed prior the release of batches, to assure the compliance of the product with cGMP and EU legislations.
contact: bru@laboratorium.hu
Batch Evaluation and Release:
Prerequisites:
- Main milestones before product launch are completed
- Necessary sample quantity (for testing + reference) is available at Eurofins
- Consumables for testing (working standard, impurity standards, placebo etc.) are available at Eurofins
- Batch documentation is available at Eurofins (for the list, contact: bru@laboratorium.hu)
- Filled and signed F20B order form for release
After Eurofins receives the samples, the necessary batch specific documents and the F20B order form, it takes a maximum of 3 working days (for maximum 20 batches) to preassess the documents (transport conditions, specification compliance etc.) and do the attributive testing. After that the samples are transferred to the QC laboratory which is the day 0 of the project.
If any part of the necessary documentation is missing samples provided must be stored under quarantine at our sample storage room.
Quarantined samples cannot be forwarded to the laboratory for QC testing!
In case all the necessary documentation has been provided to Eurofins completely, order form has to be confirmed by Eurofins and sent back to the customer.
Deadline can be calculated only from confirmation date!
Deadlines for analytical testing and release:
Non-sterile products: 20 working days
Sterile products: 23 working days
Priority option (only for non-sterile product): 15 working days
Downloadable documents:
Order form – Batch release (including analytical testing)
Main milestones in the EU release process of imported pharmaceutical finished products (PDF)
Contact:
Dr. Horgos József
+3618723697
horgos.jozsef@laboratorium.hu
