manual on management of drugs

) Enforcement
The main function of the Enforcement Division of the CDDA is to assist in
the enforcement of the Act, by verifying that all elements within the
pharmaceutical supply system comply with the regulations of the Act.
Verification by inspection includes assessment of manufacturing, distributing
organizations, wholesale and retail outlets.
Those duties are performed by the authorised officers (PDHS, RDHS, MOH,
Food & Drugs Inspectors/F&DI, Divisional Pharmacists and Public Health
Inspectors*). Chief F&DI at the Enforcement Division coordinates these
activities with the authorized officers in the provinces/regions. This division
too comes under the Director/MT&S whose office is at 120, Norris Canal
Road, Colombo 10.
* Public Health Inspectors have not been appointed as authorized officers yet
4.2 National Drug Quality Assurance Laboratory (NDQAL)
National Drug Quality Assurance Laboratory was first established in 1971 as
Drug Quality Control Laboratory at the General Hospital Colombo premises,
with its facilities limited to chemical analysis of pharmaceuticals. A modern
well-equipped laboratory with facilities for chemical, microbiological and
biological analysis of pharmaceuticals was established in 1990 with the
support from NORAD. This laboratory is situated at 120, Norris Canal Road,
Colombo 10. Director/NDQAL has been appointed as an additional approved
analyst under the provisions made by the Act
The primary function of the NDQAL is to conduct laboratory tests necessary
for determining compliance with product safety and quality requirements.
Quality testing of drug products is carried out on samples collected on random
basis at different points of the distribution; namely at pre-marketing and postmarketing
stages, and issue reports/recommendations based on the
analyses/evaluations.
Quality of a drug product is assessed by measuring its degree of conformity to
its claimed standards. The quality standards may be prescribed according to
pharmacopoeial (BP, USP, IP, Int. P, etc.) or non-pharmacopoeial
(manufacturer’s) specifications.
In the assessment of quality, the important characteristics of a drug product to
consider are its appearance, identity, purity, potency, uniformity and
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