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Guideline VBRN: Best Practice Guide for Electronic Platforms

Levi, S.
VBRN Advisory group,
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Abstract

Official Medicines Control Laboratories (OMCLs) for Immunological Veterinary Medicinal Products (IVMPs) play a vital role in ensuring the safety and efficacy of veterinary vaccines in Europe. Their responsibility includes the control and official batch release of these products before they are allowed to enter the European market, in line with EU Regulation EU 2019/6. In pursuit of efficiency, transparency, and traceability, there has been a growing interest among OMCLs in developing electronic platforms to automate the submission and certification processes (OBPR/OCABR) for veterinary vaccine lots. This “Best Practice Guide for Electronic Platforms” is designed to share insights and recommendations for implementing electronic platforms in OMCLs across Europe. Drawing upon the collective experience and expertise of OMCLs, the guide offers practical guidance on planning, designing, developing, and implementing electronic platforms for the streamlined processing of veterinary vaccine lots. It also provides valuable insights into the use of these platforms, certificate generation, and tracking Key Performance Indicators (KPIs).

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Date
2024-04-01
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EDQM, Council of Europe
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Publication type
Sci. report, recommendation, guidance doc., directive, monograph
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Keywords
batch release, electronic platform, Immunological Veterinary Medicinal Products, vaccine
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