Clinical Research Solutions
cGMP for Phase 1 Investigational Drugs: Sterile Parenteral Drug Product Manufacturing
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Understanding Analytical Method Validation
The core of my background was built upon analytical development science for biotechnology companies including Celera and Genentech. It became routine to develop analytical assays to test products...
Does your Quality System stand up to the challenge?
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
Top Takeaways from FDA’s Guidance on Data Integrity
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April. This is significant in that the last formal written guidance provided from FDA on this subject...
The 503b Outsourcing Facility Compliance Dilemma
At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...
Gravity and Quality Assurance
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...
CSV Considerations Around Data Integrity
Data integrity is a current hot topic, but not a new one, within the life sciences industries and associated product supply chains. This article will not delve into why there have been so many recent...
FDA Inspection? Rely on Your Vendors
If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the...
Are You Maximizing Your Return on Data Investment?
Generating process data is expensive: Costs include materials, process time and the focus of highly-compensated subject matter experts. Unfortunately, many organizations don’t get their money’s worth...
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...
Are You Ready for AIQ?
Do you find yourself in one of the following situations? + Your equipment has broken down due to frequent usage or wear and thus requires repair. You realize that once repaired, any equipment will...
Looking to the Cloud for your Business
computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
Clinical Research Solutions
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...
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...
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...
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...