- About Vaccine Units
- Bacterial Vaccine
Bacterial Vaccine Unit
An overview on the working of Bacterial Vaccines Unit
Bacterial Vaccines Unit (BVU) is a sub-laboratory with in Central Drugs Laboratory (CDL) and is assigned with the responsibility of testing and lot release activities of the bacterial and other combination vaccines (having one or more components of bacterial origin). The lab encourages the sample senders for technical discussions. The lab is open to
receive positive as well as negative feedback from its customers
Main source of samples received for testing and / or Lot Release
- The lab evaluates the products on quality of the vaccines
based on safety and efficacy parameters. Annually, bacterial vaccine
unit receives around 3000 batches of the various bacterial vaccines
for testing & /or pre-release certification. The batches received from
manufacturers, importers (through port authorities) and from
inspecting authorities for EPI supply are subjected to lot release.
Considering the number of batches received; the lab subjects the
samples for testing based on the track record of the manufacturer
and trend analysis. However, each such batch is subjected to at
least stringent protocol review and no batch is exempted from lot
release. For the samples received from drug inspectors, field etc.
the samples are tested as per the study orders of the Director /
Officer-in-charge of CDL. For testing pharmacopoeia / international
guidelines or other established/approved specifications are
followed to ensure the safety, efficacy and quality of the product.
This unit has qualified, trained & experienced scientists
to review the summary lot protocol and to perform the quality
control analysis of vaccine samples. Quality control tests performed
on the vaccines includes In-Vivo as well as In-Vitro assays as per
the requirements of the testing.
To make a move towards digitalization and to overcome
shortage of storage space, the lab has taken an initiative and every
manufacturer is asked to submit the soft copies of the summary lot
protocols along with hard copies. The lab intends to move towards
the paper less work in future.
Reviews the dossiers (CMC Module 3) pertaining to Bacterial or
combination vaccines submitted by the manufacturer / importers as
per the directions of the National Regulatory Authority for
Gives opinion on the Post Approval Changes is also given by the lab for
the bacterial and other combination vaccine having at least one of
the bacterial components.
Participation in the internal audit of Central Drugs Laboratory as
per the audit plan.
Assists in Quality Assurance activities.
Participates in technical discussion with manufacturers on issues
pertaining to bacterial vaccines.