Complaints and Recalls in Pharmaceuticals

All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.


Complaints and Recalls in Pharmaceuticals


When a customer or any other party (internal or external) has reported a product defect or adverse event with any of the company’s marketed products.


A procedure of retrieval or withdrawal of products known or suspected to be defective, promptly and effectively, from the market.

In context with complaints and recalls in the pharmaceuticals, any immediate response to the customer complaint can be critical because any product failure can cause harm to the customer. Product complaint management an essential component in the pharmaceutical industry from regulatory and patient compliance point of view . Whenever the product is commercialized, the post marketing surveillance will start to monitor the adverse effect on population. The complaint can be related to production, transportation and packing. This step needs uniform, single, and secured platform to manage product complaint right from initiation to the closure. Hence, the market complaints are handled with well defined procedure on higher priority. If the complaint is genuine, then a root cause analysis performed to rectify the problem and the product should be recalled from market if it is necessary.

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