There is a well-defined and independent WHO-GMP-compliant Quality Control unit with the following salient features:
- A written Quality Policy.
- Independent Quality Control Head.
- Complete documentation system with written procedures for each activity.
- Well-equipped laboratories with certified and calibrated instruments.
- Qualified & Experienced Staff / Analysts. Established in 1989 as Joint Venture with Vineland Labs, U.S.A.
- Activities of the Quality Control Department:
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- Physico-Chemical Testing
Testing of
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- Diluents, RM & PM.
- Samples of water – Potable water D.M & WFI.
- Moisture content in lyophilized vaccines.
- Residual formaldehyde -Inactivated vaccines.
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- Bio-Analytical Testing
- Microbiological and Biological Analysis of Vaccines (DS & DP).
- Stability Testing of Vaccines (DS & DP) and Diluents.
- Microbiological Testing
- Media Preparation.
- Environmental Monitoring.
- Sterility testing of vaccines (DS & DP), diluents and water samples.
- biological Testing
- Serological/ Potency testing of vaccine samples.
- QC testing in Embryonated eggs and Tissue-culture.
- Safety and Innocuity tests.
- Bio-Analytical Testing