Biopharma / Pharma

//Biopharma / Pharma

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 [...]

Week of July 1st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 to an API manufacturer, and 1 to a compounding pharmacy. We cover these 3 below: DRUGS: Foshan Jinxiong Technology Co., Ltd. (Guangdong, China) received a warning letter on June 26th 2018 based on the outcome of an inspection ending August 18th 2017. The firm [...]

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 [...]

Week of June 24th 2018 | FDA Sent These Warning Letters to Pharma Companies

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it 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. DRUGS: Henan Lihua Pharmaceutical Co. Ltd (China) received [...]

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 [...]

Week of June 17th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 15 warning letters this week -- many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover. GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st 2018, based on the outcome of an inspection conducted [...]