Expert Exchange on Good Laboratory Practice

GLP as part of conformity assessment

GLP describes a set of acknowledged rules, criteria and methods for laboratory activities and operations. Consequently, GLP also affects conformity assessment procedures by providing a framework for ensuring the quality and integrity of test data.  

Indian and German experts met on 4 September 2023 for an exchange on GLP. The hybrid event with more than 75 participants improved mutual understanding of the topic and forms a basis for further cooperation. In his opening remarks, Volkmar Stein from the German Ministry for Economic Affairs and Climate Action (Bundesministerium für Wirtschaft und Klimaschutz  – BMWK) highlighted the importance of GLP in ensuring consumer health and safety as well as environmental protection. Nishat S. Haque and Rachna Sehgal from the Bureau of Indian Standards (BIS) further emphasised the relevance of GLP and described the exchange as an important milestone for the Indo-German cooperation in this area. Dr. Shanmuga Sundaram from TÜV Rheinland underlined the dynamic developments in the field of GLP and the resulting relevance for Indo-German cooperation.

Current laboratory infrastructure in India and Germany

In two presentations, experts from BIS and TÜV Rheinland shared insights on the laboratory infrastructure in India and Germany. BIS operates multiple laboratories and has accredited more than 300 additional laboratories as part of its Lab Recognition Scheme. In this context, the experts from BIS presented the Darkarea portal, a web application through which users can access information about testing laboratories in India.

In the second presentation, experts from TÜV Rheinland led by Dr. Sundaram provided an in-depth overview of the laboratory landscape and regulatory system in Germany. The experts also emphasised the important role of quality management systems, digitalisation and sustainability in ensuring GLP. This includes the repeated testing and recalibration of Instruments and the participation in interlaboratory comparisons. Both presentations highlighted the importance of maintaining high standards in laboratory practices and management.

The following discussion focused on different tools and measures for the digitalisation of laboratories and their operations. The experts addressed the resulting challenges and opportunities for ensuring the quality of processes and test results.

Indo-German dialogue on GLP  

The exchange represents an important step in the collaboration on technical regulation and conformity assessment within the Indo-German Working Group on Quality Infrastructure. The hybrid event took place virtually and on-site at BIS in New Delhi. It was jointly organised by BIS and the team of the Global Project Quality Infrastructure in India. The exchange improved mutual understanding between Indian and German experts for the successful implementation of GLP. The interest in further collaboration on the topic remains high. Follow-up activities are already planned for the coming months. We will keep you informed about the results of the completed activities on our website.