Follow
A written or verbal report originating from a customer, retailers, physicians, field supervisor, regional sales coordinator, Medical representative, Hospitals, Regulatory agency and our employees which relates to the inadequacy of the quality, i.e.: non compliance with standards or customer requirements and includes any packaging and labeling requirements, any query regarding specifications, analytical procedure, incomplete text, and non-conformance with customer requirements should be treated as complaint.
Classification of Complaints
Market complaints to be classified as minor, major and critical.
Minor: Complaints related to physical appearance of packaging of the product.
Major: Complaints related to physical appearance of the products (e.g. broken tablets, fading, spots etc), packaging quantity (e.g. empty blister, empty cans, broken/missing actuators, empty content etc), label missing, batch printing missing etc.
Critical: Chemical property complaints related to any chemical test failure of a product, e.g. low purity, change in the impurity level and degradation and shall also include the complaints arising due to stability failure. In the event that a batch is considered to be actually or potentially harmful to user, thereby requiring a recall, follow procedure 6.9.11 in this SOP.
