Introduction

The Blood Reagent Laboratory is a notified Central Medical Device Testing Laboratory (CMDTL) by Government of India for quality control evaluation of Blood Grouping Reagents. The Laboratory has the infrastructure and expertise for testing different types of Blood Grouping Reagents and Gel cards for safe blood transfusion.

Notification

Laboratory was notified as CDL vide Gazette No. 600 E, dated 27th august, 2002, Gazette No. 908E, dated, 22nd December, 2014 and re-notified as CMDTL vide Gazette No. 2237E, dated 1st June, 2018

Accreditation

The Laboratory has a Quality Management System in place and is NABL accredited for testing of Blood grouping reagents and gel cards in accordance with ISO/IEC 17025:2017 standard for Chemical Biological tests, vide Certificate No. TC-7725.

Batch Release Testing

Laboratory has prepared different In-house reference standards using International reference standards obtained from National Institute of Biological Standards and Control (NIBSC), UK which are used for Quality Control evaluation of Blood grouping reagents. for batch release, tests are carried out as per the Indian Pharmacopoeia, Transfusion Medicine Technical Manual Second Edition, Center for Biologics Evaluation and Research (CBER) and as per in house specifications.

Monographs

A total of 9 monographs for Blood grouping reagents have been published in the Indian Pharmacopoeia

Training

Blood Reagent Laboratory has been imparting "Training of trainers for strengthening of blood services"for MedicalOfficers and Technical Personnel from various states across the country in collaboration with National Health Mission, Ministry of Health & Family Welfare Government of India and National Institute of Biologicals, Noida