Fit-for-purpose continuous improvement tools in pharmaceutical manufacturing permit ongoing risk mitigation.
By Ajay Babu Pazhayattil, M. Pharm., Eurofins Alphora Research Inc.; Marzena Ingram, Eurofins Alphora Research Inc.; and Naheed Sayeed-Desta, Sanofi Pasteur
The U.S. Food and Drug Administration (FDA) is working on implementing a reporting program allowing certain key quality metrics to be reported to the agency. Once in practice, the quality metrics initiative will improve predictability, helping the regulatory authority, industry, and patients1 in various ways. While the regulator continues to develop standard metrics for reporting, it is high time the industry turns toward implementing indices that provide warning signals on internal segments that may hinder the company’s compliance stature. The best industry use of such indices is to also help improve business efficiency problems. A great opportunity exists for pharmaceutical scientists in optimizing already commercialized large portfolios of pharmaceutical products. Continuous improvement tools enhance visibility and trigger continuous improvement projects such as reformulation, process optimization, and new technology adoption. As a matter of fact, solid dosage formulations still remain a mainstay of the overall drug products manufactured and among new molecular entities. The recent surge of sterile parenteral formulations, primarily biologics, is expected to continue. Further, typical solid dose formulations of generic drugs make up the majority of the prescription market share totaling approximately 90 percent of the prescriptions filled.2 The annotations bring to our attention the need for continuous improvement in the form of advancements in traditional formulation technologies, improving operational efficiency, and application of new technologies such as continuous manufacturing3 for marketed products.