CHP-Complaint handling process an approach in response to the dissatisfaction regarding substandard and a counterfeit drug

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Syed Zafar Abbas Zaidi

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

Counterfeit drugs are frequently referred to the manufacturer by the regulators/customers for establishing their validity. Complaint Handling Process (CHP) is basically an approach to respond to this problem via different means.It is a primarily element of Quality Management System. It has an interrelationship with different peripheral systems of Pharmaceutical industry such as RMS (Risk Management System) and CAPA (Corrective action and preventive action). For complaint investigation CAPA system stands as a framework.Multiple questions correspond to the format, patient details, adverse effectsand problems related to the product itself. Counterfeiting flourishes a prime category of complaints received. Popular medicines are very feasible to produce their counterfeit and trade with great profit margin. The study focuses the escalating utilization of counterfeit commodities in the global market. CHP System provides a base for not onlymanagerial implications but it helps to investigate and communicate the importance of using a genuine drug to the customer. Availability of spurious/ counterfeit drugs is escalating every day. It endangers life of innocent human beings. This is a burning problem that may be un-intentional or deliberate. Counterfeiting of medicines is a global phenomenon. With the increasing yearn of wealth, human are deviating from our ethics or moral principles & tasks. Right to health, which includes right to quality medicine, has been considered as an elemental right throughout the globe. In this discussion the different practices adopted worldwide to combat this menace is reviewed.

Biography :

Syed Zafar Abbas Zaidi has completed his PhD from the Department of Chemistry, University of Karachi, in 2014. He is an Assistant Manager Quality Assurance in OBS-Pakistan (formerly Merck Sharp & Dohme-Pakistan), a renowned Pharmaceutical organization. He has diversified work experience of more than 10 years, primarily Quality Assurance and Control departments. He has published 04 papers in reputed journals.