What is the correct procedure for handling a customer complaint about the quality of a medicine?

Handling customer complaints is an important part of the QMS. It affects not only customer satisfaction but also provides an important channel for identifying potential product quality issues and system deficiencies. A compliant complaint-handling process should be clearly set out in an SOP. The process starts with a detailed record of all complaint information, including the complainant’s details, product name, batch number and specific complaint. A designated person should then conduct an initial assessment to determine whether the complaint involves an adverse drug reaction or a serious quality issue. Where possible, the customer should be asked to return a sample for examination. An internal investigation should then be conducted, including checks of retained samples from the relevant batch and storage and distribution records. If the complaint concerns a manufacturing defect, the manufacturer must be notified immediately. All investigations, findings and final decisions (such as a refund, replacement or a determination that the complaint is unfounded) must be documented in a written report, and the complainant must be informed of the outcome.