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 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 …
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 …
To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be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 …
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 …
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 data from various live websites and …
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 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 …
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 …
The FDA issues warning letters as formal notifications to industry about violations that the FDA has documented during an inspection or investigation. The warning letters are publically available on the FDA website.
Reviewing the letters …
