QA Leadership
GLR QA’s Leadership for Medical Devices
At GLR laboratories, the Quality Assurance Unit is uniquely positioned to provide customized quality assurance service to clients’ projects, as per the specific regulatory requirement for the product’s testing.
A QA Auditor is specially assigned to each one of the customer’s unique products, for close monitoring and quality assurance auditing, throughout the particular product’s testing life-cycle at GLR Labs, from the time of project confirmation and product (test item) receipt, through to the study plan preparation, conduct of studies, report compilation, archival and report delivery to customer.
The assigned QA auditor follows closely, the customer’s exact requirement and expectation in the specific product’s (test item’s) handling, testing and report presentation, while assuring that all prescribed quality compliances are met as per applicable regulatory rules and guidelines, through a comprehensive monitoring and auditing programme.
Thus, the QA function plays a leadership role in the quality compliance of Medical Devices testing at GLR Laboratories.
The QA team at GLR Laboratories comprises of highly qualified (50 % PhDs) and specially trained auditors (OECD GLP Training by NGCMA, Govt. of India & ISO 17025: 2017 Training by NABL Assessors) with a combined regulated industry quality assurance experience of more than 30 years. Our regulatory experience includes submission to the DCGI, CDSCO (India), FDA (USA), various Notified Bodies for CE Marking (EU), MFDA (South Korea) and PMDA (Japan).
Certifications / Accreditations / Registrations / Endorsements
Certifications
GLR Laboratories is certified capable of conducting toxicity studies and mutagenicity studies in compliance with the OECD Principles of GLP, by the National GLP Compliance Monitoring Authority (NGCMA, Department of Science and Technology, Government of India). The current certificate number is: GLP/C-132/2019, valid from 4th April 2019 until 3rd April 2022.
This OECD GLP Certification enables global acceptance of data from GLR Laboratories by all 36 OECD member countries and the non-OECD member countries Argentina, Brazil, Malaysia, Singapore and South Africa, that together represent more than 80 % of world trade and investment.
Source:Accreditations
GLR Laboratories has been assessed and accredited in accordance with the standard ISO/IEC 17025:2017 ''General Requirements for the Competence of Testing & Calibration Laboratories'', in the field of Testing, by the National Accreditation Board for Testing and Calibration Laboratories (NABL, a constituent board of the Quality Council of India), which is a Mutual Recognition Arrangements (MRA) signatory to international bodies like International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Accreditation Co-operation (APAC), which lend international recognition to its accreditation certificates. The current certificate number is: TC-6251, issued on 3rd October 2019 and valid until 2nd October 2021.
Registrations
GLR Laboratories has been registered as a Medical Device Testing Laboratory for carrying out tests or evaluations of medical devices on behalf of manufacturers under the Medical Devices Rules, 2017, by the Central Licensing Authority - Drugs Controller General of India (Central Drugs Standards Control Organization [CDSCO], Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India). The current registration number is: TL/MD/2019/000005, issued on 7th January 2020, valid in perpetuity.
Endorsements
GLR Laboratories is registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA, Ministry of Fisheries Animal Husbandry and Dairying, Government of India), for conducting research for commercial purposes on small animals. The current registration number is 1364/PO/Rc/S/10/CPCSEA, issued on 25th November 2016, valid until 24th November 2021.