Introduction

The Blood Products Laboratory is a notified Central Drugs Laboratory (CDL) by Government of India for quality control evaluation of Blood Products. The laboratory has the infrastructure and expertise for testing different types of Blood Products. The Blood Products laboratory was set up with the aim assuring the quality of plasma derived products marketed in India. Since these biological therapeutics are inherently complex and variable, a vigilant monitoring is required to ensure the quality as well as safety of such products. Presently, Blood Products Laboratory is testing twenty three different plasma derived biological products as per statutory standards laid down in Indian Pharmacopoeia or relevant pharmacopoeia or International norms. Laboratory has successfully participated in an international collaborative study to establish the WHO 3rd international standard for thrombin organised by NIBSC, UK. Laboratory regularly participates in various international proficiency testing studies organised by EDQM, France.

Notification

Laboratory was notified as CDL vide Gazette No. 908E, dated, 22nd December, 2014

Accreditation

The Laboratory has a Quality Management System in place and is NABL accredited for testing of Blood Products 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 along with primary/secondary International Reference Standards for Quality Control evaluation of various Blood Products. For batch release, tests are carried out as per the Indian Pharmacopoeia / European Pharmacopoeia / British Pharmacopoeia / Manufacturer’s specifications.

Monographs

Blood Products Laboratory NIB contributed for revision of 9 existing Blood Products monographs in Indian Pharmacopoeia

Training

Blood Products Laboratory has been imparting Training under the National Skill Development & Hands-on Training programme organized by National Institute of Biologicals, NOIDA to Post-graduate students and to Indigenous Manufacturers to strengthen the Indian Plasma Industry.