Official Batch Protocol Review (OBPR)
The examination of the batch documentation or the documentation for the production and quality control of an immunological veterinary medicinal product is based on Article 81 of European Directive 2001/82 / EC (Community code relating to veterinary medicinal products). This review is part of the national batch release of all immunological veterinary medicinal products.
It may be administered either by the Paul-Ehrlich-Institute (PEI) or a national control laboratory of another Member State of the European Union (EU), the European Economic Area (EEA) or Switzerland, which is part of the network of Official Medicines Control Laboratories (OMCL), according to commonly agreed guidelines. The result of OBPR will be recognised accordingly by the other national control laboratories of the OMCL network.
Specifications for the pharmaceutical company defining the information on batch production and testing that has to be submitted with the application for batch release are included in special EDQM model protocol templates for manufacturing and test protocols.
Step 1: The pharmaceutical company requests the release of a batch. This application must be accompanied by the documents relating to the production and quality control of the batch.
Step 2: If no experimental testing according to OCABR is necessary, the PEI decides on the release of the batch on the basis of the submitted batch documentation. The batch must meet the criteria and specifications as laid down in the approval for the Federal Republic of Germany.
Step 3: The decision on the state batch release is issued no later than 15 working days after receipt of the complete batch documentation.
If the batch is to be marketed in one or more member states of the EU / EEA or in Switzerland, the pharmaceutical company may apply to the PEI for the issuance of a so-called EU certificate, provided that it has an authorisation in Germany for this immunological veterinary medicinal product.
If a batch has already been tested and approved by the competent authority of another Member State of the EU / EEA or Switzerland in accordance with the OBPR or OCABR Guideline, the application for release and the batch documentation must be accompanied by a corresponding EU certificate as a confirmation of batch release in this state. This certificate is recognised by the PEI and used as the basis for documentation review and batch approval. If the batch complies with the specifications laid down in the approval for the Federal Republic of Germany, the PEI will issue the notification of the national batch release within 7 working days.
Each batch release request should be accompanied by test samples of the batch to be released, even if the submission of such samples is only a prerequisite for batch release in case of expermental testing or in individual cases at the special request of the PEI. The general availability of batch samples free of charge gives the PEI the opportunity of additional quality assurance on a case by case basis. Independently of the official batch release, the PEI intends to carry out experimental checks on a random basis and for its own account. The continuous methodological balance and the exact knowledge of the batches of a particular product have proven successful in the past when problems occur and have been beneficial to all those involved in safety and cost, because in such cases the efficacy of a batch in doubt was demonstrated during its shelf-life or necessary measures could be limited to the most modest.