Barbara W. Unger

/Barbara W. Unger

About Barbara W. Unger

Barbara formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, I led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. I developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function. I was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009-2014) that summarized and published summaries of relevant GMP and supply chain related laws, regulations and guidance. Currently I co-chair the data integrity working group within Rx-360. I also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010-2014. I received a bachelor's degree in chemistry from the University of Illinois in Urbana, Illinois. Barbara W. Unger Unger Consulting Inc. www.ungerconsulting.net 805.217.9360

Week of August 26th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.

Week of August 19th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 4 warning letters this week -- 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. This week we also saw 2 untitled letters posted from inspections in 2016 (yes, 2 years ago). We cover all 4 in this post.

2015 vs 2018 – MHRA Data Integrity Guidance

MHRA published a revision to their 2015 Data Integrity Guidance. The 2018 revision, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. However, some items are more detailed in the 2018 version. We address all within this post and identify the nature of the addition, deletion, or revision.

The New FDA GMP Inspection Model

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.