Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. The cadence of publication steadily increased as ICH Q8, ICH Q10, and ICH Q11 emerged, as thought leaders sought to provide practical guidance to industry on the application of QRM. This article will focus on selected publications addressing general, rather than specific, applications of QRM.
In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.