FDA Advises Starting With the Lab When Sniffing Out Data Integrity
This article was originally published in The Gold Sheet
FDA official advises starting with laboratories when auditing contract manufacturers for data integrity. Recent warning letters and WHO notice of concern show why.
You may also be interested in...
Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.
New Year’s resolutions anyone? Generic drug maker Fresenius Kabi closed out the year with the unlucky distinction of receiving not one – but two – drug GMP warning letters from FDA last month. The agency chastised the firm for not reporting failing test results and not getting to the root cause of sterility failures. The firm was also criticized for not learning from earlier mistakes.
With data integrity problems on the rise, pharmaceutical manufacturers must ensure in auditing their contract manufacturing partners that they have the robust electronic controls needed to survive an FDA inspection. The analytical lab is a good place to start when doing audits because it's where a majority of problems are found by FDA investigators.