FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
WHITE PAPERS & CASE STUDIES
Container Closure Integrity Testing Of IV Bags
As a means to ensuring the safety of sterile products, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have provided strict guidelines for the testing of container closure systems.
High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems
Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilizing intelligent vision systems.
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Pharmaceutical Company Cuts Packaging Costs
In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.
Effective Cleaning Of BOD Bottles
Many environmental water/wastewater laboratory professionals are faced with the task of cleaning BOD Bottles. The interiors must be cleaned and rinsed completely to remove any inhibitory residues which may interfere with future tests. As these bottles have constricted necks, hand cleaning is difficult and time consuming. By Miele Professional
A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.