Medical Devices

GMP Regulatory Newsletter: Summary Scan | Week of 7/8/18

Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA. Another 2 guidance were also published this week. No guidance was published by the EMA. WHO published 1 document. The non-guidance collection included the usual sets from MHRA, EMA, [...]

Follow the Trail to Find Data Integrity Problems

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 storage. While you can start [...]

GMP Regulatory Newsletter: Summary Scan | Week of 7/1/18

Laws, Regulations, Guidance, and Concept Papers Just a few guidance documents and updates on non-guidance documents. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement: 3 warning letters. 1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified [...]

84 New FDA 483s | July 9th 2018

In the past 3 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

Who Can See Form FDA 483s, and Where Do I Get Them?

Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are public information and, thus, [...]

By | 2018-07-05T16:26:50+00:00 July 5th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Form FDA 483, Medical Devices|

GMP Regulatory Newsletter: Summary Scan | Week of 6/24/18

Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA. Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program. The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH.  Several are worth a serious read. To see the complete [...]

How to Monitor and Benchmark Your CMOs/Suppliers

Today I’d like to show you how to do supplier monitoring and benchmarking using FDAzilla Enforcement Analytics. We’ll start with a simple example of API manufacturers located outside of the United States. You can either watch this video to see how we do this or continue reading below. [NOTE: Don't have access to FDAzilla Enforcement Analytics? Get your personalized [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/17/18

Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA. FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting to see the [...]

How Do I Apply ALCOA To E-Records?

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 site as a starting [...]

By | 2018-06-21T13:33:46+00:00 June 21st, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|