Quality Control Section background

Quality Control Section

The Quality Control (QC) Section is responsible for testing and validating the safety, purity, potency, and efficacy of all vaccines, diagnostic reagents, and biological products produced by the Institute. QC serves as the final checkpoint before product release, ensuring every batch meets stringent national and international standards.

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Overview

The Quality Control Section ensures that every vaccine, antigen, and diagnostic reagent undergoes rigorous analytical and biological testing prior to release. QC activities cover raw materials, in-process samples, and final products, verifying compliance with Good Manufacturing Practices (GMP) and Veterinary Biological Standards of India.

Testing procedures are continuously reviewed and validated in alignment with OIE and WHO guidelines to maintain reliability and accuracy.

Core Functions
  • • Testing of raw materials and culture media for sterility and purity
  • • In-process control of bacterial and viral vaccine batches
  • • Final product testing for safety, potency, and efficacy
  • • Animal testing for vaccine challenge and response validation
  • • Preservation of reference strains and control samples
  • • Calibration and maintenance of analytical instruments
Laboratory Capabilities
  • • Microbiology and Virology testing laboratories
  • • Animal testing facility with containment and ethical oversight
  • • Analytical instrumentation including spectrophotometers and ELISA readers
  • • Cleanroom sample handling areas with laminar airflow systems
  • • Temperature and humidity-controlled storage for test samples
Quality Standards and Compliance

All tests are conducted as per validated Standard Operating Procedures (SOPs) following GMP and ISO 17025 principles. Results are reviewed by the QA Section before product release, ensuring transparency and traceability throughout the testing process.

Collaboration and Continuous Improvement

The QC Section collaborates closely with production and QA teams for process improvement, and participates in inter-laboratory comparison programs to maintain testing excellence. Staff undergo continuous training in analytical techniques and biosafety practices.

Commitment to Quality

Through scientific precision and strict adherence to standards, the Quality Control Section upholds the Institute’s reputation for reliability and trust in the field of veterinary biologicals.