manual on management of drugs

ANNEXURE XVII
Quality Assurance of Vaccines
Medical Research Institute (MRI) functions as the National Control
Laboratory (NCL) for vaccines and related products. MRI was nominated
as the NCL, under section 25 (2) of Cosmetic Devices and Drugs Act No.
27 of 1980 and was legally appointed by the Ministry of Health of the
Government of Sri Lanka by gazette notification No. 1052/3 of 02.11.1998.
The key function of the NCL is technical evaluation of all vaccines used in
the government immunization programme, which includes lot release and
quality testing. Lot release is done as a minimum by protocol review of all
batches of vaccines imported into the country and laboratory testing in
special situations according to the vaccine testing policy of the NCL.
Monitoring the quality and usage of vaccines and sera;
Lot release:
All vaccine batches used in the government sector should undergo lot
release from the NCL before use and the following documents and samples
should be submitted.
Summary lot protocols (including production and quality control) of
single harvests, bulk and final product
Lot release certificate from NCL of country of manufacture
5 vials from each lot of single dose vaccines / 3 vials from each lot of
multiple dose vaccines
According to the vaccine testing policy of the NCL, routine testing of
batches is done in the following situations and would require more vaccine
samples .
All new vaccines before registration
First 03 batches of new vaccines after registration
Please note that the NCL should be contacted prior to sending the samples.
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