“Retrofitting quality into a biotech firm is the worst thing you can do … Thinking you can do quality later is the biggest lie people tell themselves.” — A Chief Science Officer Quality has a less than positive reputation in some corners. People see quality as something that can stifle progress. In fact, part of…
When it comes to GxP regulation, if it wasn’t documented, it didn’t happen … and that’s a problem for the quality teams who pour countless hours into keeping their companies compliant. When the auditor arrives, the only thing that matters is proof. Unfortunately, massive spreadsheets and stacks of paper files that take time to sift…
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.
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.
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.
The COVID-19 pandemic shines a light on the importance of developing a Business Continuity Plan (BCP) early in the establishment of your business. Many fail to realize a BCP is a necessity—a necessity, like a fire extinguisher, we hope we never have to use.
I often find myself in a meeting with a client’s leadership team, where someone asks me, “How can we build more of a Quality culture?” This simple question reveals significant information about how the company operates, as well as the state of its culture.
Many deficiencies identified in FDA’s 483s and Warning Letters can be traced back to SOP deficiencies—inadequately written, communicated, monitored, and/or enforced. Well-written SOPs provide clear instructions, avoiding deviations.
Quality experts know that SOP training has positive effects on performance and success. Yet senior executives can resist even a minimum amount of training, especially when they do not operate daily in a GxP environment.
Today, we want to discuss elements that make for a strong foundation for such a program. Remember the goal is to maintain compliance while ensuring employees efficiently master required techniques and current operating procedures and protocols.
