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 …
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To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be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 …
FDA inspection – 483 citation tracking
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 …
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 …
FDA warning letters 2014 & 2015 – Finished Pharmaceuticals
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 …
FDA light touch on medical devices for patient self monitoring
Medical Device Data Systems
On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. …
Whitepaper – ISO13485 & US FDA CFR 820 Comparison
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …