First Joint Clinical Assessments (JCAs): Key Lessons for EU HTA
The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness
Quality & Compliance
If You Didn't Write It Down...
Since the day I entered the industry the mantra of "If you didn’t write it down, it didn’t happen" was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...
Quality & Compliance
Sustainable Media Program for the Pharmaceutical Industry, Part II: Tools for Successful Media Fills
Today, ProPharma's Simona Gherman adds to her series on Media Programs and media fills. Part I of this series was an overview with background information and tips. Part II focuses on what you need,...
Regulatory Sciences
FDA Issues Final Guidance on Providing Regulatory Submission in Electronic Format – The eCTD Mandate is Coming
On May 5, 2015, the Food and Drug Administration (FDA) released the final guidance on Providing Regulatory Submissions in electronic format. The guidance implements the electronic submission...
Quality & Compliance
Sustainable Media Program for the Pharmaceutical Industry, Part I: Simple and Straightforward Information and Tips
>Would your media program pass the test? The FDA inspection test, that is. In this new blog series, ProPharma Group’s Simona Gherman breaks down the FDA regulatory requirements for a successful media...
Quality & Compliance
Mergers, Acquisitions and Consolidations: Whose Validation Standards Do I Use?
If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...
FDA Sets A Deadline For Electronic Submission Of Drug Applications
In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...
Will There Ever Be An FDA-Approved Generic Insulin?
On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...
You Were Off By How Much?
Many active ingredient assay failures can be attributed to weighing and charging errors incurred during the compounding process. Even when the active ingredient is weighed and charged correctly,...
Quality & Compliance
How Do You Stay “c"?
Trying to remain compliant with the current Good Manufacturing Practices (cGMP) has its challenges and opportunities. I would like to discuss the opportunity afforded by the ASTM E2500 "Standard...
Regulatory Sciences
Drug Development Questions And The FDA - The End Of The Black Hole
Commonly during drug development, significant issues arise for which FDA input is desired but that do not merit a full face-to-face multidisciplinary milestone meeting. In many cases, sponsors are...
Learn Your Lessons Well: How Regulatory Strategies and Clinical Trial Design Affect Approvability
A recent analysis by the Tufts Center for the Study of Drug Development places the price tag of bringing a new drug to market at around $2.6 billion. The reason for this is simple: failure. Drugs...
Quality & Compliance
CAPA and the Importance of Effective Technical Writing
My apologies to you in the technical writing profession out there, but there are not too many topics that are as bland and unappealing as technical writing. Personally, I'd rather step on a sharp...
Quick Guide: Coordinating a Laboratory Move
Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...
Quality & Compliance
Lean CSV Requirements and Planning – How to Reduce Waste, Increase Value, and Maintain Compliance
The diagram below depicts an example CSV lifecycle alignment with ASTM E2500 and GAMP. Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on...
Quality & Compliance
PMP: The Benefit of Quality Knowledge
There are thousands of drug manufacturers that have a number of ongoing projects within Operations. Often times, these companies seek experienced consultants to assist/guide them to project...
