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QA and GMP are about error prevention. However, in this imperfect universe there is no such thing as an incredibly perfect system, and an essential feature of any QA system is a plan to deal with complaints, or reports of defective products, should they occur. A requirement to cover this occurs in all significant GMP guidelines. Complaints received from consumers, professionals and the trade serve as the primary means of receiving feedback on product quality after delivery. Therefore, every complaint or investigation must be evaluated by knowledgeable and responsible persons.
Drug packaging, production and distribution records, and stored samples provide the basis for evaluating the validity and seriousness of the alleged deviations initiating the complaint. The complaint file itself plays an important role in determining whether a similar complaint has been received in the lot in question, or in any other lot of the same product. Grievance evaluation serves several valuable purposes. First, there is an urgent need to ascertain whether consumers are at potential risk and to take any appropriate action. A second standard is the review of the product and its manufacturing process to establish whether any changes are needed. The third is the need to respond quickly to the customer, thereby trying to maintain trust in the product and the company.
