Biopharma / Pharma

//Biopharma / Pharma

Part 1: Drug GMP Warning Letters Data Governance and Data Integrity

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 is not the only [...]

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 [...]

Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a [...]

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|

GMP Regulatory Newsletter: Summary Scan | Week of 6/10/18

Laws, Regulations, Guidance, and Concept Papers A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material! Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products. The non-guidance area includes the usual collection from MHRA (including [...]

How to Do A Keyword Search in FDA Warning Letters

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...

86 New FDA 483s | June 18th 2018

In the past 2 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 [...]

Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. FDA reminds the public that no one is authorized to sell or distribute opioids via the internet, with or without a prescription. A total of 17 warning letters were posted this week. We cover 3 of them below. DRUGS [...]

FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level. Figure 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016. Figure 3B shows this distribution of deficiencies among [...]