Articles by Barbara Unger

  1. The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/31/2020

    This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

  2. An Analysis Of MHRA's Annual GMP Inspection Deficiencies Report 1/27/2020

    To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle. 

  3. UPDATED: New EMA Requirements On Nitrosamines — What ALL Pharma Companies Need To Know 1/7/2020

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorisation holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  4. Data Integrity: Surveying The Current Regulatory Landscape 8/4/2016

    This review of recent regulatory actions related to data integrity first explores data integrity deficiencies cited in FDA warning letters issued between FY2013 and FY2015. Then, it moves to a review of the recently published FDA draft guidance on data integrity. Finally, it addresses the finalized version of the WHO guidance on the topic.