Experimental Batch Testing
Experimental Batch Testing
Experimental batch testing of drugs is part of official batch testing, which is performed at the Paul-Ehrlich-Institut (PEI). It serves the safety, effectiveness and quality of medicines and is based on the current state of science and technology.
The PEI conducts experimental tests as part of the official batch release process for
- blood plasma-derived products such as albumins, fibrin sealants, coagulation factors, plasma protease inhibitors and virus-inactivated human plasmas
- immunoglobulin preparations
- vaccines
- test- and therapy-allergens
- sera from animals
For products derived from blood plasma, immunoglobulins and vaccines the experimental testing can also be carried out by the official drug control laboratories (OMCL) of the Member States of the European Union (EU) and the European Economic Area (EEA) and Switzerland. In Germany, this can be done either by the PEI or another OMCL. The OMCLs have joined forces in a network coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM).
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Experimental Testing of Allergens
Experimental Testing of Allergens
Official batch testing including the experimental testing of allergen preparations for therapy (therapy allergens) and in vivo diagnostics (test allergens) is carried out in Europe only by the Paul-Ehrlich-Institut (PEI).
The test methods and product specifications used in the experimental batch testing of allergens are taken from the monograph for "allergen preparations" of the European Pharmacopoeia. The European Pharmacopoeia defines or describes all important test parameters required for the testing of allergen extracts. Important test parameters are, for example, the determination of the allergenic total activity, determinations of single allergens, protein content and profile as well as the antigen profile. Important guidelines for the characterisation of allergen products by means of suitable assays as well as for the production of standards and reference materials are given in the Guideline on Allergen Products: Production and Quality Issues.
While experimental batch testing of therapeutic allergens occurs at either the intermediate or finished product, in test allergens it is performed only on the finished product. For products subject to the Therapeutic Allergen Ordenance (TAO), experimental testing is carried out on the batch of the prefabricated mixture directly before the therapeutic allergens are filled or mixed from it. If experimental testing on the finished product is not possible, it will be performed on materials of production precursors, so-called intermediates. This is necessary, for example, when native allergens have been chemically or physically modified and can no longer be clearly characterised after the modification.
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Experimental Testing of Products Made From Blood Plasma
Experimental Testing of Products Made From Blood Plasma
The legal basis for the official batch testing of blood plasma products in Germany is Section 32 of the German Medicines Act (AMG) in conjunction with the regulation on the introduction of official batch testing for blood preparations.
The Paul-Ehrlich-Institut (PEI) carries out the state batch testing for the following approved products, which are manufactured from blood plasma:
- albumins
- fibrin glue
- coagulation factors
- coagulation inhibitors
- virus-inactivated human plasmas.
In order to simplify and shorten the processing times of applications for official batch release, the pharmaceutical company may submit an application for plasma pool testing prior to manufacturing the individual finished product batches. In this case, the PEI checks the absence of various infection markers in samples of the plasma pool and issues a plasma pool certificate. This certificate may then be submitted to the PEI with requests for release of the various batches of finished products. In this case, the otherwise required examination for each infection marker covered by the Plasmapool certificate is dispensed with.
The PEI is represented as a national competent blood laboratory control within the OMCL network and performs annual tests of about 1,500 batches of blood products. It is also the WHO Collaborating Center for the Quality Assurance of Blood Products and In vitro diagnostic devices.
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Experimental Testing of Immunoglobulin Preparations
Experimental Testing of Immunoglobulin Preparations
This page is currently not available in English.
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Experimental Examination of Vaccines
Experimental Examination of Vaccines
The legal basis for official batch testing of vaccines is Section 32 of the German Medicines Act (Arzneimittelgesetz, AMG). In Germany, official batch testing of these medicines is carried out by the Paul-Ehrlich-Institut (PEI).
As official control laboratory in Germany, the PEI is represented in the OMCL network for vaccines and examines about 800 batches in the field of vaccines every year.
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Experimental Testing of Sera from Donor Animals
Experimental Testing of Sera from Donor Animals
In Germany, animal antisera for human use are subject to official batch testing pursuant to Section 32 of the German Medicines Act (AMG). Official batch testing for these products is carried out by the Paul-Ehrlich-Institut (PEI).
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Application for Batch Testing
Application for Batch Testing
Guidelines
There are specific guidelines for state batch release for blood plasma derived products, immunoglobulins, vaccines and sera from donor animals through an OMCL, the so-called Official Control Authority Batch Release Guidelines (OCABR). These product-specific OCABR guidelines specify what information and documents must be submitted for the manufacture and control of the batches, together with the application for batch testing.
How to Submit
The submission of documents is usually done electronically via the PEI-C Rebuild application. In some cases required by law, the submission of signed documents ('wet signature') is required by post.
Submission of Test Samples
Please send samples by post to the Paul-Ehrlich-Institut (PEI).
Costs
The fees payable for official batch testing can be found in the Statutory Cost Regulation for Official Duties of the Paul-Ehrlich-Institut pursuant to the German Medicinal Products (PEI-KostVO).
Address
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
Paul-Ehrlich-Str. 51-59
63225 Langen
GERMANY
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