Regulatory Sciences
Draft Guidance for Microbial Vectors Used for Gene Therapy Outlines FDA Safety Concerns
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
Medical Information Outsourcing Models
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
Which Is Best? Regression versus Control Charting
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Clinical Research Solutions
The Role of Quality for Commissioning Success
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
Quality & Compliance
Are You Ready for AIQ? (Part II)
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
Business Sustainability: A Case for Process Validation
Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...
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...
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
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...