National Institute of Biologicals (NIB), an apex autonomous Institute under the Ministry of Health & Family Welfare, Government of India convened twelve days training program on National Skill Development & Hands-on Training Programme on ‘Quality Control of Biologicals’ for M.Pharm/PhD students of Delhi Pharmaceuticals Sciences and Research University, from 03-14 June, 2019.The training program was inaugurated on 03rd June, 2019 at National Institute of Biologicals, Noida and was chaired by former, ICMR Director General & Padma Bhushan Prof. N.K Ganguly and Dr. Surinder Singh Director NIB. Along with Dr. Reba Chhabra DD (QC) Diagnostics; Dr Achla Prasad DD (QC) RPL; and the NIB scientists, bench biologists, and staff along with the faculty of Delhi Institute of Pharmaceutical Sciences and Research University (DPSRU) participated in the inaugural session.
Prof N.K.Ganguly stressed the need to strengthen quality standards and control strategies in India in the disease advancing scenario. He encouraged the participants to upgrade their skills and knowledge through the training program which is the need of the hour. Dr. Surinder Singh briefed about the journey of NIB from 1990s to 2000s with emphasis on the key role of the institute in understanding the need of promoting and protecting human health.
The training was graced by the presence of Prof. Ramesh Goyal, Vice Chancellor of Delhi Institute of Pharmaceutical Sciences and Research University (DPSRU).In his presentation on the topic Quality Control and Challenges in Biologicals Prof. Goyal, mentioned the relevance of biopharmaceuticals as a key tool in disciplines of pharmaceuticals which will help in designing the disease control strategy. Dr Surinder Singh in his introductory remarks mentioned the need to explore the various potential biopharma conjoint platforms and welcomed a joint collaboration with DPSRU agreeing on the grounds of the concurrent dynamicity of both the biological and pharma fields and come out with a unique module to work upon.
The training session for the students initiated with pre-assessment followed by lectures on GLP regulations and Biosafety practices in biomedical laboratories and disposal of biomedical waste.
The training was carried out in a structured manner with emphasis on practical learning aspects of various techniques used in the area of biologicals covering the regulatory requirements. The students were categorized into three groups and were given hands on training on various labs including vaccine laboratory, blood products laboratory , blood serology and handled various sophisticated instruments and exposed to techniques like high performance liquid chromatography (HPLC), Capillary electrophoresis, Atomic absorption spectroscopy, Bacterial endotoxin test (BET), ELISA, PCR techniques and so on.
The participants got a clear and crisp overview on Haemovigilance program of the country, challenges in the Quality control of Biosimilars, role of Artificial Intelligence in bioinformatics, Laboratory Quality Management systems (LQMS), and GMP regulations and its compliance. All the techniques were taught and lectures were delivered by eminent scientist of NIB who are working in the area of biologicals. The high light of the training was arrangement of industrial visit by NIB to Axa Parenterals, Roorkee. The industrial visit dealt with the explanatory session by the QA/QC head right from the vendor determination criteria to the storage and distribution of the produced.
The valedictory session was chaired by Dr Reba Chhabra and other scientists of NIB along with faculty Coordinator for training from DPSRU, Dr.Jaseela Majeed and faculty nominated by Vice Chancellor DPSRU Dr. Madhu Gupta . The gathering was addressed by Ms Sudha, Training Unit Head and the addressing was feedback session, where two representatives from each team, gave feedback and expressed the overall experience of the training program. The participants received certificate after the training. It was decided that both the organizations will hand hold in the future endeavors.