How to Select the "Right" CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company's needs.
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...
Problem Solving: What’s the Best Approach?
Those of you in the pharmaceutical, biotech and medical device industries who encounter process and product problems on a regular basis, you likely grimace when one lands in your lap. There is a...
Quality & Compliance
Quick Guide: cGMP for Phase 1 Investigational Drugs
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...
Tobacco Final Rule: Advice for Manufacturers
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
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For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April.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...
Everything you to need to know about Audit Trails
In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...
FDA Works to Reduce Medical Errors, Part One: Background & Overview of FDA’s Proprietary Naming Guidance
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
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...
Quality & Compliance
Value Found in FDA Warning Letter Reviews
Starting with the issuance of a 483, the stepwise FDA enforcement process can be illustrated as follows: Given the seriousness of a Seizure and Injunction scenario, not to mention potential jail time...
Supplier Qualification in the Pharmaceutical Supply Chain
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
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...
Cybersecurity in Medical Devices: Definitions from FDA's Draft Guidance
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
