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Monday, May 4, 2020

Awareness of Quality Assurance wing while verifying raw materials.

The traditional system of medicines is also playing a key role in preventive as well as supportive treatment of COVID -19 in various ways. The quality of treatment directly depends on the quality of medicines dispensing to the patients and therefore, it is necessary to focus on the selection of the superior quality of raw materials. There are two main factors now involve to creating disturbances to the quality section of any manufacturing units. The first is hurriedness to release the raw material for production as to reach medicines to the patients in time and second is curtailing of staff to maintain only 33 percent of attendance. As we know that a small mistake of the quality of medicines may spoil the whole batch.

In this situation, a hard work in the quality section will not be solved the issue to provide quality material but apart from text, we have to apply our experiences also to check the supply of the drug on the spot as a primary check-up and quarantine the materials by random sampling. Due to lockdown, there is a scarcity of materials arisen. Since, manufacturers want material anyhow to complete the public demand to serve the medicines in time. Keeping this in mind, suppliers utilizing chances to release material kept unsoled in godown for a long period. If a genuine materials has crossed its shelflife, the efficacy of the active constituents in the material would be reduced. Such materials will not be suitable to use in medicinal preparations and these materials may be referred to as sub-standard quality. If such sub-standard materials use for medicines production, the quality of medicines will not be effective and the health of the patients remains questionable. Some times,  supply may come with low quality or substandard or substituted materials. 

The chances of adulteration are also more in this situation. Many materials may be supplied by mixing similar looking materials, for instance, saffron mixed with designed coconut kernel or florets of safflower, leaves of Aegle marmelos (vilva Patra) found mixed with Murraya koenigii leaves, stolon of Glycyrrhiza glabra is with the stem of Sesbania bispinosa,  medium-sized Piper longum fruits found mixed with Phyla nodiflora dried fruits, etc, Some time semi-distilled or partly extracted materials like cloves, cumin, ajwain and coriander seeds also possible. Though, these materials possess no morphological changes but potency and efficacy wise, they are not suitable for medicines preparation and thus, they should be considered sub-standard quality. Such kind of material need not require testing on entire parameters but may be rejected on spot. In my opinion, this practice may save time in deciding the quality of materials and also to get an immediate replacement by appropriate raw materials.

 

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