<span class="archive__title-prefix>Posts Categorized:</span> Trends & Analysis

Continued from Part 1… CY2017 Data Integrity Drug GMP Warning Letters and Trends from the Past Ten Years Table 1: Lists the warning letters that include data integrity deficiencies, the date of issuance, and the country location of the facility. The country column is color-coded, and I consolidate all European countries into a single group in […]

How Do I Follow The Trail? One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: “Imagine I’m a sample arriving at your loading dock. What happens to me?” We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and […]

This Special Report represents the 3rd year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures in data integrity and data governance is an enforcement area that began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA […]

It’s easier than you think! Let’s… Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the Paper World ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use paper CRFs at a clinical investigator’s […]

A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including: FDA forms-483Establishment Inspection ReportsWarning LettersRecallsImport AlertsConsent Decree AgreementsEU 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 FY2017The MHRA data come […]

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha […]

Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign […]

FDA’s report on pharmaceutical quality for the 21st Century in 2004 put forth their vision for reorganization within the FDA that would strengthen their ability to ensure drug quality. As part of FDA’s reinvention and modernization, they created the Office of Product Quality ‘to promote “One Quality Voice” through the integration of review, inspection, surveillance, […]

The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology. Individuals from the evaluation and compliance groups for specific product types and technologies will […]

About three months ago, I decided to take a deeper dive into Artificial Intelligence (AI). While AI has been overhyped in the media, it does represent a game-changing technology that will make its way into every industry. As such, how will AI change the game in GMP Quality and Inspection Management? Before we go there, […]