The FDA published its quality management maturity (QMM) recommendation when there was a severe shortage of drugs because of a lack of quality products being developed and marketed by pharmaceutical companies. Through the QMM recommendation, companies are expected to demonstrate a deep understanding of their products (both legacy and new), and not just from a system maturity point of view.
Sanjay stressed that to acquire this deep understanding, pharma companies must develop a methodology to bring their legacy products up to par with the quality standards imposed on newer products. They can do this by re-examining the role of continuous process verification (CPV) to manage their legacy products and process knowledge, from development through commercialization to discontinuation.
“There is a false perception that annual product review (APR) and CPV are one and the same. But APR is just a subset of CPV,” Sanjay said. “CPV is a broader concept because it gives you a more holistic picture of overall product performance over a period of time. While both APR and CPV give you an indication of product performance, the current situation in most companies is that they remain disconnected. We have an opportunity to improve and align them, but this can only happen through digitalizing the entire process,” he stated.
Sanjay covered a variety of relevant and timely CPV-related topics, including:
- The ways in which COVID-19 has accelerated the need for digital CPV
- Data-driven strategies to determine the quality of legacy products
- How to develop a risk-based CPV monitoring plan for both new and legacy products
- How to leverage today’s cutting-edge digital CPV risk assessment and evaluation tools to apply QMM guidelines
About Sanjay Sharma
Sanjay is a pharmaceutical industry leader with more than 21 years of experience developing, launching, and maintaining drug supply. His results-oriented approach and application of technically sound pharmaceutical manufacturing science have enabled some of the largest organizations deliver on critical revenue targets. Sanjay worked in several Indian and MNC pharmaceutical firms namely Cipla, Dr Reddy’s Laboratories, Sandoz, Watson, Zydus and Torrent. He currently heads technology transfer and process development at Lupin.