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Abstract

The pharmaceutical industry is making every effort to meet all current requirements in terms of quality. However, in recent times, due to drastic increase in recalls of pharmaceutical product, major challenges such as increasing complexities of design and manufacturing processes, intensive globalization processes, more stringent inspection procedures, and manufacturer’s product liability and regulatory burdens have risen dramatically. Product recall could greatly damage the reputation, profitability, and brand integrity of a company, and therefore, the industry needs to deal with effective tactics for recall. In addition, safety must always be a concern of the people who manufacture these pharmaceuticals and are associated with them. The recall is usually due to company’s discovery, customer’s complaint, or regulatory board observation. The recall process involves a specific plan of action that addresses the complexity of the recall, the need for public warning, and the extent to which the recall will be checked for effectiveness. The regulatory board will review and/or recommend changes, as relevant, to the recall strategy of the firm. The critical recall information list includes product identity, brief description of the failure, product quantity produced in the distribution chain, and direct account. Product recall clashes affecting thousands of businesses each year: Sales, testing customer relationships, and disrupting supply chains.

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	JPR Solutions

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