The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.
At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, Procter & Gamble Quality Leader and Leadership Coach Steve Greer provided a compelling, true story about a scuba diving incident and used the lessons learned as an analogy for how to ensure that pharma quality systems function properly.
In addition to the FDA Quality Metrics Site Visit Program discussed in Part 1 of this article, the agency also has a Quality Metrics Feedback Program, which aims to obtain more information about quality metrics used within the industry.
Procter and Gamble’s Steve Greer discusses his company’s experience participating in the FDA Quality Metrics Site Visit Program.
Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.
Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 3 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her insight into the best way to prepare for virtual inspections, including how to always be ready, how to go about reviewing documents, and which documents FDA is likely to request for review.
A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
Part 2 of this series focuses on Thermo Fisher Scientific and its use of virtual reality and mixed reality platforms to create a state-of-the-art system that it has successfully used in virtual inspections, including with both clients and the European Medicines Agency (EMA).
Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?
FDA has halted most in-person manufacturing facility inspections during the COVID-19 pandemic, but some physical inspections are still being performed. How is the agency deciding which firms to inspect? And what is the chance that your firm will be inspected?
Microbiological Issues with Aseptic Processing and Lyophilization: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
In the third case study in this series, FDA National Drug Expert Ileana Barreto-Petit presents a case study of lyophilization issues and reflects on quality culture.