manual on management of drugs

x. Details of any preservative added if indicated on the label.
xi. Any other remarks
In the case of liquid or semisolid preparations (mixtures, elixirs, solutions,
applications, creams etc.), only intact (unopened) packs should be sent.
A separate report will be issued for every sample of the drug product
submitted, based on an evaluation of the same through laboratory analysis and
other relevant scientific evidence, considering the batch/lot number. Hence
the samples from different batches should be submitted in separate containers.
Where there are complaints as to the potency and the toxic effects of a
particular drug product, it is always advisable to submit the samples from the
same container used for issuing the drug to the patients along with another
unopened (intact) pack of the same drug product of the same batch from the
stores.
Whenever a sample is submitted with the complaint of microbial
contamination or discolouration in bulk packs, in addition to the packs with
the observed defect, at least two intact (unopened) packs of the same batch/lot
should be sent.
When submitting samples of drug products which require special storage
conditions (controlled temperature such as 2-8 0 C etc), it is important that all
necessary arrangements are made to ensure the maintenance of cold chain
until the sample is received at NDQAL.
Further information, if necessary should be obtained from the Director,
NDQAL.
(Specimen request form is in annexure X)
Handling of quality failure of drug products
Considering the NDQAL recommendations, D/MT&S will inform D/MSD to
issue circulars explaining the action to be taken on a batch/batches/product
detected with non-conformity to their claimed specifications for state sector
institutions. In the case of private sector Director/MT & S himself will issue a
circular.
Recommended action could be:
1. To withhold the batch/batches/product as a preliminary precaution
2. To withdraw the batch/batches / product
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