New Version of 'Haemovigil Software' has been launched by National Coordinating Centre for Haemovigilance Programme - NIB w.e.f 1st May 2016    

Locale of the Administrative Block
BSL-2 spacious State of the Art Laboratory Block
Product Testing Laboratories
Product Testing Laboratories
  1. National Institute of Biologicals an autonomous Institution under the Ministry of Health & Family Welfare (MOHFW)-Government of India is a premier Scientific Organization and a Centre of Excellence to ensure quality of biologicals and vaccines in the country.
  2. The institute responsibly assures and reviews the quality of number of  Biological products available through domestic manufacturers or imports. The operations are carried out in the state of the art Facility of the Institute and in close coordination with Government of India regulatory authorities as Office of Drug Controller of India, Indian Pharmacopeia's Commission.
    With the current science and technology leading to the development of newer biologicals in the domestic market,  the testing and specifications may vary for each specific products which  requires  an improved understanding of quality and safety issues.In recent years the licensing and quality control for manufacturer and National Regulatory Authorities alike has become even more complex. With this overall objective and to strengthen the regulations of biologicals in India, NIB, which is supported by the authorities constituted of Governing body and General body of the Institute plays a vital role.

     

Sample Receipt & Report Dispatch Unit National Reference Standards Sera Panel

Manufacturing and QC Protocols

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Sample Receipt and Report Dispatch Unit  (SRRDU) Procedure.

  •  SRRDU  has been set up as independent unit in 2008.   The sample receipt unit being the main entry point of all samples to the Institute for testing, this unit has been accredited by NABL for elaborate documentation procedures. The Standard Operating Procedures (SOPs) have been amended to regulate Sample receipt to make the system flexible

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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 Document for Industry : submission of stability data and related documents for Review & Expert opinion for granting post approval changes in shelf-life of Recombinant Products & Therapeutic Monoclonal Antibodies 

(Last Date : 31.05.16)

   

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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