National Institute of Biologicals, an autonomous institute under the Ministry of Health & Family Welfare set up for the quality assessment of biological products manufactured indigenously and imported in the country, works in close coordination with the Regulatory Authorities such the as Drug Controller General of India and the Indian Pharmacopoeia Commission, and strives to maintain high standards by:
Recruiting scientific and technical personnel with educational qualifications and experience commensurate with their responsibilities through open advertisement as per recruitment rules approved by the Ministry of Health & FW.
Training scientists as per National & International standards on: QA-QC, bio-safety practices, GLP, GMP, & ISO requirements.
Placing equipment used for testing biological products under AMC and calibrating annually by an NABL accredited laboratory or by Original Equipment Manufacturer (OEM).
Daily monitoring of temperature of walk-in-cold rooms, walk-in-freezers, refrigerators used for storage of test kits, test samples and consumables.
Coding samples received for testing before these are sent to the laboratories.
Testing biological products as per protocols under Indian and other pharmacopeia and approved standard operating procedures monitoring turnaround time for testing.
Restricting access to the laboratories by authorized personnel only through a Biometric system.
Promoting participation in External Quality Assessment schemes where available or Internal Quality Assessment.
Procuring consumables after assessing the requirements, suitability of the specifications and sources.
Having a redressal system for complaints of clients.
Keeping abreast of technical information by having a well stocked library, and by organizing lectures by internal and external experts and periodic workshops.
Holding regular meetings of the management committee chaired by Director for timely preventive and corrective action
Nominating senior scientists as nodal officers for corrective and preventive action.
