Introduction

Enzymes and Hormones Laboratory has been set up for Quality control (QC) testing of various Biotherapeutic Enzymes and Hormones for its identity, potency, safety and other tests as applicable to the product. The lab also functions towards the development of monograph for incorporation in Indian Pharmacopoeia, monograph test method verification, test method standardizations for new biologicals such as rare disease therapeutics. The laboratory participates in proficiency testing, Inter-Laboratory Collaborative (ILC) Studies with national and international organizations.

Notification

Enzymes and Hormones Laboratory got notified as Central Drugs Laboratory (CDL) vide the Gazette of India, Extraordinary, Notification No. : G.S.R. 250 (E) - Part-II - Section 3 - Sub- Section (i) dated 15th March, 2017 for Streptokinase (Natural and Recombinant); Human Chorionic Gonadotropin (hCG); Human Menopausal Gonadotropin (hMG).

Accreditation

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

Batch Release Testing

The laboratory carries out Quality Control testing using various International Reference Standards/ Certified Reference Materials which are procured from various international organizations and also using Reference Materials provided by the manufacturer if primary standards are not available. The laboratory also prepares in-house working standards which are used in routine testing. The allowable limits for the products will be followed as per respective monographs of current editions of Pharmacopoeias like Indian Pharmacopoeia, European Pharmacopoeia, British pharmacopoeia, United States Pharmacopoeia etc. or manufacturer’s specifications for non-pharmacopoeial products.

In addition, the laboratory performs inter laboratory testing for Bacterial Endotoxin test (BET) for Blood and blood related products, vaccines.

Monograph contributions to Indian Pharmacopoeia

The laboratory is actively involved in the development of monographs, review of test parameters and monograph verification for Indian Pharmacopoeia.

Training

The Laboratory provides hands-on-training to graduate and post graduate students of various universities of India on quality control evaluation of Enzymes & Hormones through various institutional training programs conducted by the institute from time to time.

Scientific Collaboration

The laboratory participated in “International Collaborative Study for development of 4th international reference standard of Streptokinase” with NIBSC, UK. The study was for potency assay for preparation of 4th international reference standard of streptokinase for Quality Control aspects.

Joint inspections

Part of joint inspection team of Scientists and CDSCO/State drug officials in conducting cGMP inspections for various manufacturing premises.

Publications

Laboratory has credited to 05 publications in various renowned Scientific Journals in the field of Biologicals.