manual on management of drugs

9. Monitoring of quality of drugs;
(i)Drugs supplied by the SPC should be registered at CDDA and
conform to international standards as specified in the British
Pharmacopoeia, International Pharmacopoeia, United States
Pharmacopoeia and Indian Pharmacopoeia etc.
(ii) Nevertheless, quality defects (due to issues relating to efficacy,
safety and quality) and adverse drug reactions may be encountered by
prescribing officers/other relevant officers.
a) These problems on quality should be communicated to
D/MSD,D/MTS and Director / NDQAL as specified in Chapter 8.
b) The format for reporting quality issues is given in Annexure X
Information on Adverse Drug Reactions (ADR)
(iii) All adverse drug reactions should be reported to the ADRmonitoring
centre of the Pharmacology Department / University of
Colombo, in the form provided in Annexure – XVI
In addition ADRs should be reported to Director/MSD, Director / MTS and
Director / NDQAL.
Quality Assurance of Vaccines
(1).The quality assurance of vaccines is done by the Medical Research
Institute (MRI), Additional Approved Analyst for vaccines and related
products Annexure xvii
Monitoring the quality and usage of vaccines and sera ;
In respect of all problems of vaccine 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, storage
condition, maintenance of the cold chain, reaction caused, dosage used etc. to
National Control Lab for Vaccines/MRI (Head/Virology Department, MRI –
contact No. 2698660, Res. 2597723)
Sample size for Q.A. Test – i. Single dose vials - 05 vials
ii. Multi dose vials - 03 vials
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