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 5/13/18

Laws, Regulations, Guidance, and Concept Papers A lite week for new guidance publications:  2 each from FDA and EMA. Among the non-guidance publications are 2 of particular interest: 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in Regulatory Science. The [...]

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. 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. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later collection are the MHRA GCP Inspection Metrics Changes in the [...]

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. To see the complete list of laws, [...]

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of [...]

GMP Regulatory Newsletter: Summary Scan | Week of 4/22/18

Guidance documents are available from the FDA and EMA this week across a variety of topics.  Lots to read there from both the FDA and EMA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement publications were busy this week: 3 drug warning letters from [...]

Week of Apr 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

Maybe back to more normal with 16 warning letters posted this week: The Center for Tobacco Products issued 9 warning letters 3 were issued to manufacturers of finished pharmaceuticals (all are OTC manufacturers located outside the US) 2 were issued to compounding pharmacies So far in CY2018, 14 warning letters out of a total of 33 drug GMP warning [...]

GMP Regulatory Newsletter: Summary Scan | Week of 4/15/18

Laws, Regulations, Guidance, and Concept Papers FDA published several new guidance, both draft and final, this week: 2 are administrative 2 address quality 1 addresses format for submission of vaccines data Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published 2 [...]