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

GMP Regulatory Newsletter: Summary Scan | Week of 7/8/18

Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA. Another 2 guidance were also published this week. No guidance was published by the EMA. WHO published 1 document. The non-guidance collection included the usual sets from MHRA, EMA, [...]

Week of July 1st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 to an API manufacturer, and 1 to a compounding pharmacy. We cover these 3 below: DRUGS: Foshan Jinxiong Technology Co., Ltd. (Guangdong, China) received a warning letter on June 26th 2018 based on the outcome of an inspection ending August 18th 2017. The firm [...]

GMP Regulatory Newsletter: Summary Scan | Week of 7/1/18

Laws, Regulations, Guidance, and Concept Papers Just a few guidance documents and updates on non-guidance documents. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement: 3 warning letters. 1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified [...]

Week of June 24th 2018 | FDA Sent These Warning Letters to Pharma Companies

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. DRUGS: Henan Lihua Pharmaceutical Co. Ltd (China) received [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/24/18

Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA. Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program. The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH.  Several are worth a serious read. To see the complete [...]

Week of June 17th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 15 warning letters this week -- many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover. GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st 2018, based on the outcome of an inspection conducted [...]

Part 1: Drug GMP Warning Letters Data Governance and Data Integrity

This Special Report represents the 3rd year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures in data integrity and data governance is an enforcement area that began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA is not the only [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/17/18

Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA. FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting to see the [...]

Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a [...]