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THE PHARMA REVIEW (NOVEMBER DECEMBER 2019)

Quality Risk Management (QRM) in Pharma Life Sciences

Debashish M Banerjee

Introduction:

 

In most countries compliance with good manufacturing practices (GMP), medicines regulatory activities and inspections, together with supply chain controls throughout the product life-cycle, provide good assurance that risks are largely controlled.

 
However, where control is less effective, patients may be put at risk through the production of medicines of inadequate quality. The assessment of individual risks related to specific products and starting materials and the recognition of hazards at specific stages of production or distribution should permit regulatory authorities to improve control of medicines by increasing the effectiveness of their activities within the limits of the available resources.

 

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