Updated FDA 483 citations analytics tool
As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have …
FDA inspection – 483 citation tracking
FDA Citation Tracking Tool Updated December 2020
I’m excited to share that QikSolve has a new tool to track and trend all FDA inspection and 483 citations from 2008 to 2015, the tool dynamically scrapes …
False Claims in CBD Product Advertisements: The FDA Crackdown
FDA Crackdowns on False Claims for Medicinal Cannabis Products
False Claims, Fake Medicines and Counterfeit News – Why the U.S. FDA is cracking down on cannabis-product advertising claims and unsubstantiated efficacy statements.
Are U.S. medicinal cannabis …
Dangers of Fake Marijuana
Fake medicines and substandard supplements are increasingly being distributed and consumed across the globe. This is partially due to thousands of unauthorised online pharmacies selling substandard medications, counterfeited pharmaceuticals and other fake drugs. It’s …
Counterfeit Medications | Global Statistics | Australia Risks
Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.
How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across …
US FDA issue a Technical Specifications Document for Quality Metrics
To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be submitted. The document contains …
US FDA continue to find Data Integrity violations
Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …
USA FDA issues a warning letter to another compounding pharmacy
Compounding pharmacies are in the FDA’s headlights again, with another pharmacy receiving a warning letter after an inspection, these inspections normal have findings relating to poor design of pharmacy clean rooms, i.e. CFR 211.42.
Highlighted …
Continuous Product Quality Reviews – why are they so much work?
Continuous Product Quality Reviews and FDA quality metrics
Are annual PQRs an old school way of thinking?
A few years ago I was working on a non-pharma, large scale ERP project for a multi-national. During the …
Top 10 FDA Warning Letter Findings for Finished Pharmaceuticals in 2015
After reviewing the 27 warning letters issued for finished pharmaceuticals in 2015 (a decrease from the 33 issued letters in 2014) the following top 10 hit list has been assembled.
#10 Subpart J: Records and …