The drug testing laboratory (DTL) under the Tamil Nadu drug control administration (TN DCA) is gearing up to apply for accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) for all areas of testing and calibration.
NABL accreditation will give recognition to Chennai DTL as competent in carrying out testing and calibrations adhering to the uniform quality standards set by the Quality Council of India (QCI).
The department has invited tenders for engaging NABL approved consultants to assist the DTL to achieve the accreditation in accordance with the international standard ISO / IEC 17025 and ISO 15189.
“The job of consultant is very rigorous. He has to develop SOPs for each testing and calibration, and it is his duty to prepare data and document duties and responsibilities of NABL staff, prepare procedures for recognition of sample collection, develop quality manuals and give training to the analysts at the laboratory for assessment and accreditation by NABL experts.
All consultancy services to meet the requirements of the QCI standards will be provided by him and he will oversee all the work in the lab. We will select three consultants’ applications and choose one expert from them”, said the director of the DCA, M Sivabalan.
Currently, the department has only one laboratory, which is set up in the premises of the head office at Teynampet in Chennai. Another government laboratory is the King Institute of Preventive Medicine and Research (KIPMR), located in Guindy, which is mainly intended to carry out testing of parenteral preparations but also carries out testing of drug samples collected by the regulators.
This lab is under the direct control of the directorate of medical education (DME).
Sivabalan said the new drug testing lab set up in Madurai will be commissioned in January or February of next year. As soon as it is inaugurated, the department will make another request for accreditation from the national accreditation board.
He said before retiring from service he will attain NABL accreditation for these two laboratories. The director is supposed to retire in June 2022.
To a question why the department delayed in processing an application for NABL accreditation for its drug testing laboratory located in Chennai, the DC said a lack of technically skilled consultants, government permission, and availability of funds were the problems that hampered it from applying so far.
He claimed that Chennai DTL will be the first NABL accredited government drug testing laboratory in south India.
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