Locale of the Administrative Block
BSL-2 spacious State of Art the laboratory Block
Product Testing Laboratories
Hands on Training during Workshops at NIB
CPCSEA registered Animal House with facilty of beautiful Kitchen garden for Organic Food and Vermicomposting
  1. National Institute of Biologicals has been established as an autonomous organization under the Ministry of Health & Family Welfare (MOH&Fw)-Government of India. registered in January 1992 ( vide No. S-22590) under the Societies Registration Act 1860. laid down in Bye-Laws of  the institute.
    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 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 regulations of  biologicals in India , NIB which supported by the authorities  constituted of   Governing body and General Body of the Institute plays a vital role.
Sample Receipt Sera Panels National Reference Standards


Sample receipt and Report dispatch procedure

  • Samples of various biologicals that are referred by the forwarding /Statutory Authority for quality analysis are checked to confirm that they meet the statutory requirements or required criteria as mentioned in sample requirements section.

  • Sample Receipt and forwarding

      • Receipt of samples from the Drug Controller General of India      /Authority    Verification of   supporting documents, quantity,      shelf life, fees for testing    samples
      • Rejection of samples
      • Coding of samples
      • Sample forwarding to designated labs
      • Receipt of coded samples in product testing laboratories

    • Generation of Test Analysis Report

            • Testing of coded samples
      •  Decoding of samples after testing  critical parameters
      • Receiving Documents for  Scrutiny of Manufacturing and QC      protocols
      •  Final test report preparation
      • Tracking of Samples  for its Turn Around Time (TAT)
      • Generation of Certificate of Analysis (CoA)

    •   CoA generation by the Product testing laboratory
    •   CoA prepared by the Analyst and Approved by the Laboratory        Head
    •   Authorization of the Test Report 


    Dispatch of Certificate of Analysis (CoA)

    •   Release of the Certificate of Analysis with a covering letter       by the SRRD unit Incharge to the sample sender  
    •   Dispatch of Report by the SRRD unit
    •   Tracking of sample Report status by the  Manufacturer /       Importer/ Authorities

    Complaints

      1. Complaints, if any, are treated as confidential and given due consideration unless otherwise desired by the Government or by law.Complaints can be through any means of communication e.g. letters, e-mails, fax, and telephones (to be followed by written complaint).
      1. All stored samples received for quality testing at NIB are finally destroyed as per standard operating procedures of discarding stored samples.

     

    Documents required for the sample submission.

    1.  Copy of import license ( imported samples)
    2.  Certificate of Analysis from the manufacturer/NCL
    3.  Batch release certificate from NCL/NCA
    4.  Name of three countries where the product is being marketed
    5.  Certificate to the effect that the product has not been                   withdrawn from the market of the country of origin and               exporting countries
    6.  Manufacturing and QC protocols of the product.

     

    Quantity Required

    Immunodiagnostic Lab
    Blood grouping Reagent Lab
    Enzymes and Harmone Lab
    Recombinant Lab
    Blood Products lab

     
     

    Sample Tracking


    Trainings and Workshops

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