manual on management of drugs

Director, National Drug Quality Assurance Laboratory,
120, Norris Canal Road, Colombo 10. (Tele: 011-2687741, 011-2687743/4;
Fax: 011-2687742; E-mail: govndq@sltnet.lk)
The method of collection and dispatch of such samples has been
communicated to the Provincial Directors, Regional Directors and other
Heads of Institutions by the Director General of Health Services by his letter
LAC/60/89 of 08.08.1990. (annexure VIII)
Complaints from private sector prescribers should be routed through the
Director /MT&S
An authorized officer who collects samples of drug products under section
22(1) (a) of the CDD Act for test, examination, and analysis should strictly
adhere to the procedure specified under Part-XI of the regulations of the Act.
(Annexure IX )
Following procedure shall be adopted in submitting samples of drug products
to NDQAL
Collection and submission of samples
In collecting a sample for quality testing from bulk packs, an intact (unopened
pack) is preferred. However, if this practice is not possible, the minimum
required amount of dosage units indicated in the Table 7 should be packed in
a sealed plastic bag and this bag should then be placed in a suitable rigid
airtight container and sent for quality testing.
The label on such container must indicate the following. When practical,
attach an original label to the container. If the label is hand written, following
information should be provided.
i. Name of the product (Generic / Brand)
ii. Specifications (state whether B.P., U.S.P., I.P, N.F., etc.)
iii. Strength of the product (i.e. amount of active ingredients)
iv. Batch number / Lot number
v. Date of manufacture (if any)
vi. Date of expiry
vii. Manufacturer’s name and address.
viii. Quantity submitted.
ix. Storage requirements stated on the label.
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