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

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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


Point 39 of Directive 2004/27/EC replaces the text of article 51(b) of the original medicinal products for human use Directive with the following text:

In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of the medicinal products in accordance with the requirements of the marketing authorisation. 1 [Emphasis added]

It is this statement from the directives that requires that a company wishing to market its product within the EU have testing conducted on every batch of that product in one of the 27 EU member countries.

Other Locations for Testing: Mutual Recognition Agreements

In addition to the EU, there are other political and economic groupings in the geographical region of Europe. The directives and the decisions of the EMEA are also agreed to by the European Economic Area (EEA); which comprises the EU member states plus the three additional countries listed in the bottom half of Table 1. Testing conducted in these three countries is also acceptable for product release in the EU.


Table 2. EU good manufacturing practice mutual recognition agreements (MRAs)
A third mechanism exists to allow testing conducted outside the EU to be accepted: mutual recognition agreements (MRAs) covering good manufacturing practices (GMPs) for the product under consideration. The current status of EU MRAs covering GMPs is shown in Table 2.

Thus, if a medicinal product is to be marketed in Europe (i.e., the geographical region comprising the 27 EU member states plus Iceland, Liechtenstein, Norway, and Switzerland, it must be tested against the EMEA-approved specification in one of the 33 countries with fully operational agreements (if it is a blood-derived biological product) or 34 countries (if it is not a blood-derived biological). Biological products tested in Japan or any form of pharmaceutical product tested in the US must be retested.

Testing conducted in Europe is accepted in the US, provided the testing facility has been approved by the US FDA. Many companies thus consider basing worldwide testing capabilities in Europe to minimize the need for repeat testing. For the rest of this article, the term Europe will be used to refer to the 27 EU member states, plus Iceland, Liechtenstein, Norway, and Switzerland.


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