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Drug Survey Report (2014 - 2016)   :  :   National Workshop on Laboratory Quality Management System in Diagnostics from September 05-07, 2017

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 conditions 

 for purchase of :

 

1. Sera Panels

 

2. National Reference Standards

 

 

 

Revised specification/criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kits

 
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 15197:2003

 

Turnaround time for testing 

 

 

 

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 Biotherapeutic Products and Therapeutic Monoclonal Antibodies

 

 

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

PROPOSED FOR COMMENTS :

 

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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