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

As I was re-reading MHRA’s GXP guide for data integrity several weeks ago, the concept of “right environment” outlined in section 5 caused me to pause and think; and I have been pondering the significance of this idea ever since. “Right Environment” I have always had the belief that Quality Culture and Data Integrity are […]

FDA recently published the 12-page CDER Office of Pharmaceutical Quality Report on the State of Pharmaceutical Quality. It includes a wealth of data collected over different time periods: FY2009-2018 for inspection outcomes, 2016-2018 for product quality defects, 2017-2018 for Site Catalogue and 2018 for the Product Catalogue. Interestingly, inspection data gathered by European agency inspections […]

Note: This post has been updated; originally published on January 26th, 2017. Preparing for GMP inspections, particularly pre-approval 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 and […]

In case you missed it, the first part of this series can be found here. Now that we reviewed the top-level data integrity (DI) trends, we next get into the specifics of what the FDA is actually citing. This post will walk through our analysis and tagging methodologies, and we will share our preliminary results. […]

Data Integrity (DI) is, perhaps, the most important concept in Drug Manufacturing. Drug Manufacturing is an incredibly complex process, requiring sophisticated science and instrumentation at every step of production and storage. If you cannot trust the data of the process and its results, then can you really trust anything? Accordingly, DI is amongst the top […]

FDA issued the first warning letter that cites failure to comply with requirements of the November, 2013 Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act. This warning letter was issued to McKesson Corporation in San Francisco CA on February 7, 2019, based on observations from a form 483 issued at the close […]

Just when you think you know what to expect from the FDA, they go and shake things up. This is a developing story, but the implications for companies involved in clinical trials are clear. Both European and US regulators expect data integrity when it comes to clinical data and are increasingly willing to cite problems […]

If you’re just joining us, take a look at parts one and two. Enforcement There aren’t many examples to draw on to demonstrate the issues with enforcement when a clinical service provider isn’t a CRO. Why is that? When FDA conducts an inspection, they must link findings directly back to predicate rule requirements (e.g., 21 […]

If you missed the first part in this series, you can find it here. EDC Example Nearly all sponsors use EDC technologies. Let’s zoom in for a closer look at a simplified example. 312.62(b) requires investigators “to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the […]

When is a CRO not a CRO? And why does that make enforcement hard? (Hint: it’s all about delegation.) What do the following companies have in common? Electronic data capture (EDC) software providers Central image / electrocardiogram (ECG) / spirometry readers Central clinical labs Electronic patient reported outcome (ePRO) software providers They’re not Clinical Research Organizations. […]