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Article

Hitendra Shah

Covid-19: Critical Quality Measures for Pharmaceutical Production

You may be aware that, about 25% of revenue is generated through the Pharmaceutical domain. Now considering the current Covid-19 pandemic situation, Pharma manufacturing is considered as essential services and still working during this period. But one point we should not forget that considering the current situation the Pharma companies are running with some practical problems which may be directly or indirectly impact on the compliance level of the products manufactured during the lock down / unlock period and overall cGMP compliance.

If we follow the GM Pprinciples correctly, there will not be any non-conformance or product failure.As, we all aware about basic GMP principles, we will not much focus on GMP principles, but will discuss the points which are normally not focused.Due to this pandemic situation, pharmaceutical companies are facing lot of problems. Hence, it is not good practice to raise deviation for each problem. So, you can prepare consistent compliance plan (CCP). On the basis of this plan, holistically you can evaluate the areas need to impacted and move on further on basis of evaluation of calculated risk. The actions can be taken by raising quality notifications.Duetosomanyrestrictionsand lock down Pharma companies may be suffering from one or moreproblems;The problems may be- Lack of Sufficient manpower, The weak moment of the people working in the area led to more deviations, investigations, OOS or OOTetc.Unavailability of the transportation – Impact on receipt of input materials, dispatch of the finished goods.More focus on current product analysis and less focus on stability sample testing.Less support from third parties for example pest control, calibration agencies, laundries etc.Lack of sufficient quality oversight etc. and many more. There are so many such problems. Hence, I would like to suggest you to prepare the consistent compliance plan. The plan should be based on the risk assessment considering your organization practices. You may not perform fresh risk assessment. You can refer earlier risk assessment, review it, evaluate whether all the control measures or mitigation plan suggested are being followed or not.Also, you need to develop a review mechanism of the activities performed.We need to have problem solving approach to prepare consistent compliance plan.

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