By James Jardine
Modern pharmaceutical regulatory and manufacturing models have made great advances assuring and confirming quality of products for all of us. Some of the most notable milestone advancements have included requiring developers to clinically confirm safety and efficacy prior to petitioning the government for permission to manufacture a new product on a commercial scale and empowering the U.S. Food and Drug Administration (FDA) to require manufacturers to comply with good manufacturing practice (GMP) regulations. Compliance with GMPs provides the assurance that, once produced, a product meets safety and quality specifications before it is distributed.
Early in the process, industry responded by making a large-scale effort to develop and implement quality practices designed to assure or confirm product quality. Data was subsequently collected and analyzed, and the trends that emerged continue to drive the fast-paced evolution of modern quality systems, new models and advanced digital tools. Successful development and implementation of these tools requires that the modern pharmaceutical workforce speak the language of quality fluently and with clarity.
The further industry moves from the initial application of the early practices and subsequent systems, the more challenging it has become to differentiate between the many facets of quality concepts. The intent of this white paper is to clarify those concepts and bring their fundamentals into focus, including:
- The relationship between control and the assurance of quality.
- The nature of quality control (QC), within the larger construct of quality assurance (QA).
- The components of quality assurance within a larger quality management system (QMS).