Wednesday, August 24, 2016

Quality Risk Management

The pharmaceutical industries are considered to be the most critical industry as the substandard medicines may put the life of patients who are consuming these products at risk.  

There are different regulatory authority who keeps an eye on the pharmaceutical industries.. these regulatory authorities include not only Indian authorities but also authorities of those countries where the pharmaceutical manufacturers  are dispatching  there products.

The regulatory are not only focusing on the good manufacturing practices in the manufacturing unit but also the control on the supply chain throughout the life cycle of the product.

Therefore in order to keep a control on the risk, a risk assessment shall be done. In past this risk assessment was conducted by doing hazard analysis critical control point (HACCP), traditionally used by the food safety management system but subsequently to other industries as well. Recently the quality risk assessment that is more relevant to pharmaceutical industries has wider scope and thus more effective than HACCP. 

The guidelines on Quality risk assessment to protect patients in terms of quality safety and efficacy of medicines is described in WHO TRS No. 981 Annex 2.

Quality risk asseement can be adopted proactively or retrospectively and can be applied by both medicine regulatory authority (MRA) and pharmacuetical manufacturers. It should be the integral part of the pharmacuetical quality system.

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