FDA Increased scrutiny with regard to Process Validation/Qualification & Calibration - 24 Oct 2012
Between October 2010 through September 2011 the US Food & Drug Administration (FDA) issued a total of 39 Warning Letters to domestic and foreign drug manufacturing companies on violations against the requirements defined in 21 CFR 211.192 (Production Record Review). A detailed analysis of the warning letters suggests;
- An increase in the number of non US based companies that have been cited by the FDA for non-compliance
- A third of the companies violating the stated requirements are located outside the US
Missing or insufficient process validation is one of the top criticised deficiencies in 2011 by the FDA. Other deficiencies include deviations associated with critical parameters in the validation batch which has not been properly investigated; non validated re-processing, validation of mixing times or lack thereof; no data to demonstrate validation of holding time for bulk material; missing review/release of a validation report.
A review of the FDA citations for the period in review suggest that the agency is keen on validation of water systems, computer system validations & handling of deviations, access control to systems & facilities, Environmental monitoring including air flow pattern / smoke studies and issues typically associated with tardy requalification e.g. lack of documented Change Control.