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 5/20/18

Laws, Regulations, Guidance, and Concept Papers: FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011. EMA published 1 on IMPs for consultation. HPRA, WHO, Health Canada, and CDSCO each published 1. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence [...]

Week of May 13th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA published 4 warning letters this week: 2 were issued for unapproved new drugs 2 were issued to drug firms addressed below DRUGS: Ei LLC (Kannapolis, NC) received a warning letter on April 16th 2018 based on the outcome of an inspection ending October 6th 2017. Based on the nature of manufacturing and the identified deficiencies, it is interesting [...]

Part 1: The FDA and MHRA’s Most Recent Drug Inspection Observations

INTRODUCTION A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including: FDA forms-483 Establishment Inspection Reports Warning Letters Recalls Import Alerts Consent Decree Agreements EU Reports of GMDP Noncompliance  This 3-part article series presents recent publications of GMP drug product inspection data from CDER and MHRA: The CDER data are from drug inspections conducted in FY2017 [...]

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 [...]