At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.
At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.
As oligonucleotide therapeutics development continues to accelerate, there are necessary steps to execute and assure quality of oligonucleotide Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs). The basis of this work begins with “good science” as well as a substantial understanding of the drug development process. Here are the major areas to consider. Clearly Delineate…
An article examining recent GMP inspection data from two prominent regulatory bodies notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.
An article examining recent GMP inspection data from two prominent regulatory bodies notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.
In the September issue of the FDA Group’s “Insider Newsletter,” Dr. Carmody discusses FDA’s proposed Quality Metrics program, new expectations for device cybersecurity, and a warning letter citing faulty study data. Find the story here.
Judy Carmody, PhD – Founder and Principal Consultant, Carmody Quality Solutions, LLC. Affiliations: Member, Society of Quality Assurance (SQA), New England Regional Chapter Society of Quality Assurance (NERCSQA), Association of GXP Excellence (AGXPE), and Women in Bio A Roadmap to Quality: Performing CMC Activities with an NDA In Mind Oligonucleotide therapeutics development continues…
By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC As we close out 2020, which can’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment. I don’t need to tell anyone in a quality role how COVID plans and precautions have added an entire…
How people take steps to institutionalize a Voluntary Quality Assurance (VQA)® Culture in their organization. We explore a blog post by the FDA’s Janet Woodcock and developing a new quality rating system to bring transparency to life sciences.
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.
Equipment qualification, including software validation for automated systems, is the process of demonstrating that equipment performs as intended. “As intended” is truly the key part of this process …
