Batch Release Testing: A Geographical Driver For Outsourcing in Europe - A good understanding of European regulations governing batch release testing will facilitate your collaboration with a contract


Batch Release Testing: A Geographical Driver For Outsourcing in Europe
A good understanding of European regulations governing batch release testing will facilitate your collaboration with a contract laboratory.

BioPharm International Supplements

Sampling and Distribution

In addition to requiring that batch release testing be conducted in Europe, the European GMPs require that the samples used for batch release testing be taken from the bulk shipment on European soil; sampling at the manufacturing site outside Europe and sending the samples separately to the testing laboratory is not permitted. The manufacturer must thus have a mechanism for sampling at the importation site or distribution center in Europe.

The importer must have a Qualified Person (QP) named on its authorization. The QP has a role defined in European GMPs and is ultimately responsible for releasing each batch of the product onto the market. The QP is required to review all manufacturing records and testing results for the batch to ensure the quality of the product. Provision must be made in any agreement with a contract testing laboratory to ensure full notification of the QP of not only the results but also of any problems with the conduct of the testing.

Batch Testing for Clinical Trials

Directive 2003/94/EC states in article 11:

When the (investigational medicinal) products are imported from third countries, analytical control shall not be mandatory. 2

The conduct of clinical trials in Europe requires that investigational medicinal products (IMPs) be manufactured and labeled under conditions that meet the requirements of European GMPs, taking into account the developmental stage of the product. As with licensed products, the final release of the IMP for trials in Europe is conducted by a QP. In the clinical trial situation, however, the QP may have to conduct some assessments on a case-by-case basis because the manufacturing and distribution of the products is not as well established as would be the case for a marketed product. For example, although the regulations do not require batch release testing in Europe for an IMP that has been manufactured and tested in a third country, the QP may request that retesting be conducted to verify that there has been no harm to product quality during storage and distribution. European regulations recognize QPs for IMPs as a separate class of QP owing to the differences between the type of data and situations reviewed for IMPs and fully authorized marketed products.

Analytical methods for IMPs are not validated to the same extent as those for licensed products; the potential comparability of results from retesting to those generated by the manufacturer must be realistically assessed when considering the benefit of retesting.

The labeling of IMPs for early-phase clinical trials often is conducted at the trial site. If a product is shipped in an unlabeled form, the potential for mix-up is increased and a QP may well request limited testing (e.g., identity, protein concentration, or some other quantitative measure if multiple dose strengths are involved in the trial) on receipt at the labeling site.


The requirement of European legislation to have every batch of a marketed medicinal product tested on European soil creates the need for a company to have a testing laboratory in the European geographical region. If a company does not possess such facilities, the testing will have to be outsourced. Contract facilities in Europe recognize this need and provide the service to non-European based manufacturers through long-term agreements to the mutual benefit of both parties.

Niall Dinwoodie is head of product characterization, biopharmaceutical services, at Charles River, Edinburgh, UK, +44 1875 618313,


1. European Commission Directive 2004/27/EC, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Point 39. 2004 Mar 31. Brussels, Belgium.

2. European Commission Directive 2003/94/EC, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Article 11. 2003 Oct 8.

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