1. Poster # 96
POS 1
NATIONAL INSTITUTE OF BIOLOGICALS – “Major Milestones in Quality Control testing of Immunodiagnostic Kits"
Mr. P.S.Chandranand*, Dr. Reba Chhabra, Dr. R.K.Sharma, Dr. Richa Baranwal, Mr. Rajeev Kumar, Dr. Manjula Kiran, Dr. Anoop Kumar, Dr.Surinder Singh,
Dr.Gaby Vercauteren, Dr.Madhur Gupta
IMMUNODIAGNOSTIC KITS & MOLECULAR DIAGNOSTICS LABORATORY
NATIONAL INSTITUTE OF BIOLOGICALS,
A 32, Sector 62, NOIDA, UTTAR PRADESH
(Ministry of Health & Family Welfare) Government of India.
Objective: Quality Control testing of Immunodiagnostic kits (Serology & Molecular kits)
Introduction
National Institute of Biologicals (NIB) had been set up in 1992 as an apex autonomous Institute under the administrative control of the Ministry of Health & Family Welfare, Government of India for promoting and protecting human health through various activities assigned to it.
The mandate of the Institute includes ensuring provision of quality biological drugs i.e. Biotherapeutics & In-vitro diagnostics, Vaccines, including therapeutic monoclonal antibodies used by patients suffering from cancer and autoimmune diseases by engaging cutting edge scientific technologies and science based testing.
Conclusions & References
NIB has been designated as “Support Cell” for WHO Prequalification Programme for In-vitro Diagnostics dated on
Designated as WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg & Syphilis in-vitro diagnostic assays (WHO CC No.IND-148)
Notified as Central Medical Device Testing Laboratory on 1st June 2018, vide Gazette No.S.O.2237(E).
Functions as NCL
Establishment of National Reference Standards
ISO 17025:2005
Effective Internal Quality Control measures
Good Regulatory Practices (GRP)
GMP Inspections
QC testing
Figure 2. NIB designated as “Support Cell” for WHO Prequalification Programme
for In-vitro Diagnostics dated on
Figure 1. Lab Activities of IDK&MDL
Immunodiagnostic Kits & Molecular Diagnostic Laboratory
(IDK & MDL) - Designation as Central Drugs Laboratory.
The Immunodiagnostic Kits & Molecular Diagnostic Laboratory has been declared as a Central Drugs Laboratory for Immunodiagnostic Kits since the year 2002 and re-notified in the year 2014.
Immunodiagnostic Kits & Molecular Diagnostic Laboratory has been conducting Quality testing of indigenously manufactured and imported kits (Rapid, ELISA, Confirmatory, CLIA & ELFA Kits) for HIV, HCV, HBV, HBsAg & syphilis which are forwarded by CDSCO/Port Offices/Indigenous Manufacturers/Feld Samples/Govt. Medical Supply.
Figure 3. Designated as WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg & Syphilis in-vitro diagnostic assays (WJO CC No.IND-148).