Abnormal Toxicity, Pyrogen Testing

CHEMRTL has standardized quality control parameters () which included identification, sterility, abnormal toxicity, pyrogen testing, estimation of PRP content by ribose assay/ phosphorus assay, residual moisture content, molecular size determination by HPLC & immunogenicity assay, using seven batches of four different Hib TT conjugate vaccines. All quality control (QC) parameters standardized are as per the specifications of Indian Pharmacopoeia, European Pharmacopoeia and WHO recommendations.

Test for viability

Test for Virulence
Residual moisture content
Quantity of samples required for testing
Quantity Required

Scrutiny of Protocols
Information required to be submitted for evaluation of QC tests on final containers of BCG vaccine (lyophilized) is as follows:

Indigenous manufacturer :
Batch release certificate of manufacturer.
Certificate of analysis ( COA)of Manufacturer.
Summary protocol for production and testing.
Manufacturing protocols (for new manufacturer).