By Guy Wingate, PhD, VP and Compliance Officer, GSK
This article is based on content from the presentation, “Moving from Quality Control to Quality Assurance” held during the ISPE Proactive Compliance Conference on 13-14 January 2014 by Dr. Guy Wingate, VP and Compliance Officer (Global Manufacturing and Supply), GSK. As reflected in the theme of the conference, a collective challenge facing the industry is to achieve proactive compliance. This involves effective management and control of the manufacturing environment to avoid problems rather than just responding to problems after they have happened.
As it applies to many of us, this means assuring sustained higher performance (often during a period of significant change) with no nasty surprises. Central to our thinking must be the person at the end of our supply chain and their trust in us to comply with regulatory requirements and ensure the products we make are fit for purpose. In the pharmaceutical industry, the Quality Department is playing an increasingly pivotal role in running a sustainably profitable business that is also committed to meeting the expectations of the patient and the public. Executive managers, R&D, manufacturing, and sales and marketing all feel the pressures of productivity challenges, organizational changes and increasing regulatory requirements, but the fundamentals of quality and compliance must never be compromised. The implementation of an effective quality management system allows manufacturers to meet their ethical and regulatory obligations. It is good business sense to remove defects, reduce deviations and eliminate waste. To achieve the highest level of safety, purity, and efficacy of drug products, quality management teams are moving beyond Quality Control (QC) and into Quality Assurance (QA). Today’s modern businesses are becoming more proactive and less reactive.
The World Health Organization defines Quality Control (QC) as “the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical.”3 The purpose of QC is to ensure the safety and efficacy of a finished drug product before it is released to the public. Supporting quality systems need to detect whether items such as raw materials, components, containers, labeling and packaging fail to meet pre-existing specifications. The QC Department is responsible for conducting this work as well as testing the finished product to ensure it meets regulatory requirements. For pharmaceuticals, QC may involve analytical procedures ranging from simple substance screenings to complex pharmacopoeia monographs.
This Article is published with permission from the International Society of Pharmaceutical Engineering (ISPE), and Pharmaceutical Engineering Magazine