manual on management of drugs

Unsatisfactory clinical response, adverse reactions and bad storage
conditions:
In respect of all problems of vaccines and sera relating to unsatisfactory
clinical responses, adverse reactions and exposure to bad storage conditions has
to be reported within 24 hours by telephone and followed up with samples as
specified below with detail report relevant to the product (lot number, expiry date,
manufacture etc.), storage conditions, maintenance of the cold chain, reactions
caused, dosage applied etc (sample sending form appears in annexure XVI can be
used) addressed to the National Control Laboratory (Head / Dept of Vaccine
Quality Control, MRL Contact No. 2698660, 2693532-4 Res. 2597723). Advice
and approval regarding further use of the batches should be sought from the
Epidemiologist for all EPI vaccines and from the Director Medical Supplies
Division for all Non-EPI vaccines.
Please note that the NCL should be contacted prior to sending the samples.
Sample size for Q.A test-
(1) Single dose vials: sterility test - 5 vials, safety test - 20 vials (2) Multiple dose
vials:
sterility test - 3 vials, safety test - 3 vials
N.B. To be sent in a vaccine carrier maintaining cold chain with copies of all
relevant documents.
(2) Same procedure should be followed as pharmaceuticals regarding the handling
of product recalling.
Organization structure of the National Control Laboratory of Vaccines
DGHS
Technical Advisory
Committee
DDG (LS)
D/MRI
D\MT&S
Head / NCL
97
Dept of Vaccine
QC