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

It has been an interesting two years, to say the least! We have seen unprecedented upheaval in FDA activities from drug approvals to routine inspections and enforcement. It became apparent sometime in mid-2020 that the pandemic was going to be with us for a while and health authorities scrambled to address what this meant for […]

Over the past two years, several pharmaceutical firms have received Emergency Use Authorization (EUA) for COVID vaccines and therapeutic products. Although the EUAs can be dry reading with a lot of boilerplate type text, in some instances, these documents and other memoranda provide insight into FDA’s ongoing decision-making process balancing the public health needs with […]

[Editor’s Note: This post has been updated; originally published on June 13, 2019.] Preparing for GMP inspections, particularly preapproval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.This becomes especially complex for start-up companies that are virtual, or essentially virtual, and rely on contract manufacturers […]

[Editor’s Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems Senior GMP Expert Barbara W. Unger. Part I of her analysis includes geographic data, overall trends, and top chapters and annexes cited.] Next, we look at the deficiencies identified in Chapter 1, Annex 15, and Annex […]

[Editor’s Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will look more in-depth at deficiencies related to Chapter 1, Annex 15, and Annex 1.] The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has taken a different approach in the publication of the GMP deficiencies […]

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions. The actions include FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data, which address drug […]

It is 2020, do you know what your vendors/suppliers/contract manufacturing organizations are doing? Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance with GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors. Below is a […]

This is Part 4 of our series on virtual agency inspections. In this part, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection. In Part 3, she provided insight into the best way to prepare for virtual inspections, including how to always be ready, how to review documents, and […]

This is Part 3 of our series on virtual agency inspections. In this part, former FDA investigator Ricki Chase provides her insight into the best way to prepare for virtual inspections, including how to always be ready, how to go about reviewing documents, and which documents FDA is likely to request for review. Next time, […]

This is Part 2 of our four-part series on virtual inspections we review a state-of-the-art virtual inspection platform using mixed reality technology. In Part 1, former FDA executive Howard Sklamberg reviewed the current inspection landscape and what may trigger an inspection these days. In Part 3 of our series on virtual agency inspections, former FDA […]