GMP, GCP & Quality Control

Biography

Biography: Dharmvir Uppal

Abstract

New paradigm approach for manufacturing excellence and quality standards will enhance the links among industry players, patients and providers. In many industries, particularly the pharmaceuticals industry, the tight regulatory necessities and the challenges of staying competitive in a fast-changing environment are not only increasing the stress on sales, output and organize the different production functions, but also on quality inspection/assurance sections. The QA persons are now working to keep control of good quality, costing, durability and speed, while also complying with regulations. If this is to be achieved, quality assurance must become a proactive process which ensures that product manufacture adheres to specific standards and strives to continuously improve results and eliminate errors. In a nutshell, products should be “fit for purpose” and “first time right”. By improving process confidence and efficiency, quality guarantee can bring about prompt and constructive operational performance which still observes all requirements from statuary point of view. To make sure the stability of this achievement over the medium to long stretch, quality confirmation also required to follow quality improvement initiatives, abolish pursuit which do not give value addition, minimize the process time need to maintain and resolve quality issues, and lessen reappearance of deviations. A holistic approach of QA process optimization and organization can generate a quality culture across a pharmaceutical organization and help to overcome coming challenges. The main reason for optimization of process is to focus on value adding activities so that value and responsiveness to the customer are maximized and waste, delays are eliminated. Lean practices should be applied in an organization’s structure and processes to encourage continuous improvement.