Articles by Barbara Unger
-
What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?
5/2/2017
This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency). The CDER data and the MHRA data come from GMP inspections conducted in 2016.
-
Is GMP Quality System Auditing Fundamentally Flawed? A Data Integrity Alternative
2/27/2017
Pharmaceutical inspection approaches rely on the evaluation of several or all components of the quality system: quality, production, laboratory, materials, facilities and equipment, and packaging and labeling. One area where it has serious limitations, however, is in the assessment of data management and data integrity.
-
An Analysis Of FDA FY2016 Drug GMP Warning Letters
1/16/2017
This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).
-
Comparing Recent Data Management/Integrity Guidances From MHRA, WHO, & PIC/S
12/13/2016
Over the past two years, several major regulatory authorities have published new guidance documents addressing data management and data integrity in the pharmaceutical industry.
-
Comparing Recent Data Management/Integrity Guidances: FDA, EMA, & China FDA
11/16/2016
In 2015 and 2016, six major international regulatory authorities published guidance documents addressing data management and data integrity. Two of the guidances — the draft guidance published by the U.S. Food and Drug Administration (FDA) in April 2016 and the guidance posted by the European Medicines Agency (EMA) in August 2016, take a question and answer approach.
-
What Recent FDA Enforcement Actions In The EU Mean For FDA/EMA Cooperation
10/6/2016
FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.
-
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.
-
An Analysis Of Recent CDER Observation & Warning Letter Data
7/1/2016
The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.
-
Tips For Identifying And Correcting Data Integrity Deficiencies In Your Organization
5/3/2016
Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.
-
Data Integrity: Understanding Global Regulations & Past Enforcement Actions
4/1/2016
In this article, we will address the regulations and guidance published in this area, and review data integrity-related enforcement actions taken over the past 10+ years.