Abstract

RECENT TRENDS IN PHARMACEUTICAL QUALITY ASSURANCE: AN OVERVIEW

Jyoti Mundhe* and Amjad Ali

ABSTRACT

Pharmaceutical quality assurance is that the total of all activities and responsibilities needed to make sure that the medication that reaches the patient is safe, effective, and acceptable to the patient. It is wide move thought covering all matters that on an individual basis or jointly influence the standard of a product. Within the space of pharmaceutical quality; Food and drug administration (FDA) proclaimed planned amendments to "Current Good Manufacturing Practices" (cGMP) in 2002, with a stress on establishing a twenty first century outlook on pharmaceutical producing so as to ascertain a additional systematic science and risk primarily based approach to the event of pharmaceutical product. Pharmaceutical business is consistently looking out the ways that to make sure and enhance product safety, quality and effectualness. However, drug remembers, producing failure value, rescale problems and regulative burden in recent past turn out immense challenge for business. In ancient, the merchandise quality and performance area unit preponderantly ensured by ending testing, with restricted understanding of method and pivotal process parameters.

Keywords: Quality Assurance, Corrective and Preventive Action, Hazard Analysis and Critical Control Points, Process Analytical Technology, QbD, Good Automated Manufacturing Practices.