Participations in Collaborative Studies of 

National & International Organizations

 

S.No.  Name of Study  Collaborator  Period of Study Name of NIB Laboratory Status
1. Workshop on Laboratory Quality Management System in Biotherapeutics Clinical Development Services Agency (CDSA) - THSTI - DBT One Year Quality Management Unit 1. LQMS in Biotherapeutics completed

2. LQMS in Diagnostics proposed in Feb 2017

2. National Reference Standard preparation of Filgrastim 6 Laboratories (NIB, Filgrastim Stakeholders, & USP) 2015 - 2017 Recombinant Product Laboratory Candidate selection is underway
3. National Reference Standard preparation of Insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Report compiled
4. The 1st WHO reference reagent for the biological activities of Rituximab-like monoclonal antibodies NIBSC, UK March 2016 to

May 2016

Therapeutic Monoclonal Antibody Laboratory Results of bioassay communicated to NIBSC
5. National Reference Standard preparation Filgrastim 6 Laboratories (NIB, Filhrastim Stakeholders, & USP) 2015 - 2017 Recombinant Product Laboratory Candidate Selectionis is underway
6. National Reference Standard preparation of insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Results are received from all labs. Preliminary Report compiled
7. The 1st WHO reference reagent for the biological activities of Rituximab-like monoclonal antibodies NIBSC, UK March 2016 to

May 2016

Therapeutic Monoclonal Antibody Laboratory Samples under Evaluation
8. Development of Techniques and Reagents for Quality Control of Clinically important Indigenous Allergen Extracts ( Cockroach and Moth)

1. Dr. Achla Prasad, S-I

 

2. Dr. M.K. Agarwal

 

3. Dr. Deepak Talwar 

Ongoing work on allergen standardisation undertaken at NIB Allergen Testing Lab

Work in Progress

9. Method verification studies for development of IP monograph for rituximab drug product and drug substance Indigenous manufacturers, IPC & CDSCO March to July 2015 Therapeutic Monoclonal Antibody Lab Ongoing
10. WHO Collaborative Study to assess the suitability of a candidate 3rd WHO IS for HBsAg for use in serology assays NIBSC, U.K Dec, 2013 Infection Diagnostics Lab Completed.

Report published in Expert Committee on Biological Standardization Geneva 13 to 17 October 2014 with study coordinator Dr. Dianna Wilkinson WHO/BS/2014.2241

 

11. Method verification studies for development of IP monograph for Rituximab drug product and drug substance Manufacturers of Rituximab Jan - July

2015

Therapeutic Monoclonal Antibody Laboratory Phase - I study Initiated

 

 

ARCHIVE(2013-2014)

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013

 

Turnaround time for testing 

PROPOSED FOR COMMENTS :

 

 

   

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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