manual on management of drugs

ioavailability. Further, in appraising quality of products, their packaging and
labeling are examined to ascertain if they are adequate.
a) Pre-marketing stage
At this stage, samples of drug products submitted by:
Director/MT&S during the drug registration process
Chairman/SPC - tender samples or pre-consignment samples
Director/MSD-pre-consignment samples are assessed for their
conformity to specifications claimed.
b)Post-marketing stage
At the post-marketing stage, random samples are collected from both
government institutions and private sector pharmacies.
Particular attention is accorded to products,
1. that are commonly used
2. potentially dangerous
3. unstable under local conditions of storage
4. difficult to formulate properly
5. known to be associated with bioavailability problems.
Post-marketing quality surveillance in the government sector has been
expanded to testing of drugs available at RMSDs, Teaching hospitals,
Provincial Hospitals, District General Hospitals, Base Hospitals and
Divisional Hospitals as part of a regular quality assurance programme.
Officers of the NDQAL will also visit these health institutions periodically
and collect samples for testing under this quality-testing programme.
Authorised officers also may collect samples from government health
institutions for analysis when necessary.
Post marketing quality surveillance in the private sector has been expanded to
testing of drugs in the pharmacies and other organizations. Collection of such
samples is usually done by Authorised officers and submitted for analysis.
Prescriber’s complaints on product quality and adverse reactions are also
investigated at the NDQAL. State sector institutions may send any suspected
product directly to NDQAL.
Prescribers are requested to submit such samples to:
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