DEPARTMENT OF QUALITY MANAGEMENT SYSTEM (QMS)

A brief Note about the Department:

Vision is to enhance and protect animal health, production and productivity as well as human health by providing Quality Vaccines and best & quick services.

The Department of Quality Management System (QMS) supplements the efforts of cGMP laboratories of the Institute to achieve the overall goals of meeting customer’s and Institute’s requirements.

The QMS department has been striving through its QA/QC/SAH sections to maintain and observe all core elements of QMS such as.

  1. The organization’s quality policy and quality objectives
  2. Standard Operating Procedures, instructions, and records/documents
  3. Data management
  4. In house quality checks
  5. Customer satisfaction from product quality
  6. Quality analysis etc.

Different section of QMS and their activities/ services include:

1. Quality Assurance Section:

  1. Ensuring GLP and GMP standards in the process of manufacturing veterinary vaccines and diagnostics as per the Schedule L and Schedule M of Drugs and Cosmetics Act 1940, Government of India and Indian Pharmacopoeia (Veterinary Monographs).
  2. Application of Quality Assurance (QA) system for consistency in quality of veterinary vaccines and diagnostics produced at the Institute under the regulation of Drugs and Cosmetics Act, 1940.
  3. Quality Assurance Section is mainly involved in documentation, Quality monitoring & review, Quality Policy, training, Calibration and Validation, Conformance to standards, Annual medical check-up and self-inspection.

2. Quality Control Section:

  1. Quality Control Section is primarily responsible for the quality control of the various biological products manufactured in IAH&VB. Various tests prescribed for the different biological products produced at the institute are assayed as per the protocols prescribed by the Indian pharmacopoeia from time to time.

3. Small Animal House:

  1. Providing laboratory animals for vaccine testing. Fifteen Standard operating procedures are maintained in the small animal house to carry out routine works as per CPCSEA guidelines to ensure animal safety and health.

Facilities Available:

  1. Documentation room at QAS to safeguard the important cGMP documents.
  2. Testing laboratory at QCS to test the vaccines for sterility and animal testing facility to check for the safety and potency of the vaccines.
  3. QCS is equipped with Type 2B Biosafety cabinets to carry out Sterility testing and Stability chambers to test the stability of vaccines - Accelerated and real-time.
  4. Animal house where all the laboratory animals (Rabbits, Guinea pigs and Mice) are bred and reared. Animals are utilised for the purpose of vaccine testing and research. Animal house is CPCSEA certified facility.

Projects and Schemes:

  1. 1. RKVY funded infrastructure Project on “Designing and execution of Animal challenge facility as per cGMP for upgradation of Vaccine Quality Control Lab for the supply of high-Quality Vaccines to livestock and Poultry farming community” – Phase I and Phase II.