This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.
This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.
This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.
This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development.
Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.
We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principle Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.
This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations.
Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.
A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.
This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.