DMF changes will impact packaging suppliers—and potentially pharma companies, too
DMF changes will impact packaging suppliers—and potentially pharma companies, too
May 04, 2016
Pharmaceutical manufacturers have been submitting applications electronically to FDA for years. So the agency’s announcement that it intends to switch its current paper system for accepting Drug Master File (DMF) information to an electronic one...
FDA will reject noncompliant DMF submissions, says agency during webcast
FDA will reject noncompliant DMF submissions, says agency during webcast
May 04, 2016
Come May 5, 2017, all Drug Master File (DMF) submissions will need to be filed electronically with FDA in a specific format, or they will be rejected. Such was the word from FDA during its CDER Small Business and Industry Assistance (CDER SBIA) on...
FDA's CDRH posts list of proposed guidance development in 2016 as well as final guidance to be reviewed
FDA's CDRH posts list of proposed guidance development in 2016 as well as final guidance to be reviewed
Jan 06, 2016
FDA's Center for Devices and Radiological Health has posted a list of the guidance documents it plans to publish in fiscal year 2016 as either final or draft guidances. It has also posted a list of previously issued final guidances for which the...
Unannounced audits: First reflections
Dec 28, 2015
Packaging, sterilization, and assembling are among the critical processes that could be evaluated.By Peter Drechsler, Team Leader, Unannounced Audits, BSI Germany; Gert Bos, Head of Regulatory and Clinical Affairs, BSI Healthcare; and Paul Sim...
Dispensing trial drugs for home use
Dec 20, 2015
CPSC outlines child-resistant packaging guidelines for manufacturers. The U.S. Consumer Product Safety Commission (CPSC) administers the Poison Prevention Packaging Act (PPPA) and its regulations. Congress enacted this law in 1970 to address the...
Learn about changes to USP packaging chapters at Pharmapack North America
Dec 12, 2015
Several packaging chapters within the U.S. Pharmacopeia—including some mandatory ones—are now being revised and updated, which could significantly influence pharmaceutical packaging development and specifications (tests, methods, and acceptance...
Insects prompt Baxter voluntary recall of two lots of IV solutions
Dec 04, 2015
Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter, according to a July 17 FDA press release. The particulate matter...
17 years ago, FDA clarified packaging’s importance
Nov 25, 2015
In my look back at 20 years of sterile medical device packaging to kick off our 20th anniversary celebration, I heard some industry members talk about experiencing increased scrutiny from FDA. What has transpired?There is no question that the 1996...
High-barrier packaging for healthcare
Nov 12, 2015
New line is essentially two individual lines in a series, offering the flexibility to run as two independent lines or as a single, tandem line.Barrier packaging for healthcare applications has some of the most demanding functional requirements in...
Make sure alternative wine packaging complies with federal requirements
Make sure alternative wine packaging complies with federal requirements
Mar 11, 2015
Innovative designs for packaging wine have taken off in recent years. Although the proverbial bag-in-box design has been around for more than 20 years, the use of PET as a replacement for glass bottles for wine has been around for less than a...
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