In fiscal 2011 the US Food and Drug Administration (FDA) sent biopharma manufacturing-related warning letters to 52 facilities. Close to half of these included an observation about failure to thoroughly investigate batch failure.
“Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has been already distributed”, the FDA wrote. Sandoz, Lonza, Merck KGaA, and 10s of other biopharma manufacturers were hit with this criticism last year.
In the manufacturing-related warning letters analysed by in-PharmaTechnologist the FDA made 211 numbered observations. Failure to investigate a batch accounted for more than 10 per cent of these violations.
Another common FDA complaint, covering a range of activities, was the failure to set up or follow written rules. One-third of all observations made by FDA inspectors were on this topic. Many of the written procedure complaints were linked to prevention of microbiological contamination.
“Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile”, the FDA wrote, in one form or another, in almost one-quarter its warning letters. GlaxoSmithKline and APP received this observation.
Write it down
A similar number of companies were criticised for lacking “written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess.”
The finding reiterates the point, made by FDA speakers at industry conferences, that companies should clearly and thoroughly document their procedures and activities. Other companies were warned last year for lacking written rules for investigating out-of-specification results.