Barbara W. Unger

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She 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. Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief   Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016.  Two of the guidances, the draft from FDA published in April 2016 and the guidance from …

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3 Key Learnings from the PDA/FDA Joint Conference

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence OVERALL:  This is the 25th anniversary of the PDA/FDA conference and many of the presentations provided evidence of the significant progress made in research and medicine during this time.  It was fascinating to stand back for a few moments to see just …

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Sterility Assurance and Cross Contamination

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence Forms 483 Addressing Sterility Assurance and Cross-Contamination  Along with data integrity, deficiencies in sterility assurance and the potential for product or API contamination identified during FDA inspections often lead to warning letters. Also many product recalls are based on lack of sterility …

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The Story of 3 Consent Decrees

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties. Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies. It …

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EU vs. FDA: My Inspectors are More Rigorous Than Yours

by Barbara Unger, FDAzilla GMP Quality Expert FDA and the EU have taken serious enforcement actions against several firms in the others geographic jurisdiction in calendar year 2016.  Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours type represents an unofficial test of sorts as these two agencies move to rely more on each other’s inspections.   These inspections may …

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5 FEATURES TO LOOK FOR IN A WARNING LETTER

5 FEATURES TO LOOK FOR IN A WARNING LETTER Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter.   Often it is possible …

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Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief   The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.  I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison.  The guidance is structured in a Q&A …

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