Indan Journal of Medical Research Indan Journal of Medical Research Indan Journal of Medical Research Indan Journal of Medical Research
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Year : 2017  |  Volume : 146  |  Issue : 4  |  Page : 459-467

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues

1 ICMR-National Institute of Virology, Pune, India
2 Asark Engineers Pvt. Ltd., New Delhi, India

Correspondence Address:
Dr. Devendra T Mourya
Indian Council for Medical Research-National Institute of Virology, Sus Road, Pashan, Pune 411 021, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijmr.IJMR_974_16

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With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

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