Market complaints in pharmaceuticals: a brief review on its handling, investigation and reporting

Krishna, Vamshi T and Kumar, Lalit and Reddy, Sreenivasa M and Muddukrishna, BS and Pai, Girish K (2013) Market complaints in pharmaceuticals: a brief review on its handling, investigation and reporting. Research Journal of Pharmacy and Technology, 6 (11). pp. 1314-1316. ISSN 0974-3618

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Abstract

Any product launched in the market can receive a “Market Complaint” if the product is not meeting the customer requirements or may be for the presence of any critical defects. For instance, it can be product of any area like fast moving consumer goods, electronic gadgets, cosmetics and medicinal product etc. When it comes to medicinal product, it is expected to be of highest quality and efficacious. A product is safe and efficacious provided the medicinal product meets certain important criterions with respect to parameters like safety, identity, strength, purity and quality. In day to day life, a medicinal product can also receive a market complaint. Unlike any other product, here in this case, the user is a patient and hence its impact and implications are very serious in nature. A patient is already suffering from sickness or serious illness depending on the disease state and therefore a medicinal product is expected to be safe for usage, efficacious (or) of best quality as expected by the patient communi y. Quality is the responsibility of all personnel involved in manufacturing a product, its testing and release. A strong Quality Assurance (QA) system with commitment for quality at plant level will reflect positively on product quality resulting in a product with zero defects. A manufacturing unit with sincere QA team will be able to deliver a defect free medicinal product to patients. In this article, we have tried to outline the important aspects of market complaints, various types, its handling, investigation and reporting. In a nut shell, it is very much essential to have competent personnel at levels during manufacturing. Finally a strong regulatory authority for implementing the rules and regulations with adherence to guidelines from time to time will help the patient in receiving right quality of medicines in right time.

Item Type: Article
Uncontrolled Keywords: Market complaint; critical defects; regulatory authority and investigation.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Manipal
Date Deposited: 30 Nov 2013 11:36
Last Modified: 30 Nov 2013 11:36
URI: http://eprints.manipal.edu/id/eprint/137868

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