Many of the deviations mentioned in FDA Warning Letters refer to the review of the batch documentation. After 2007, violations of CFR 211.192 (Production Record Review) were again the most frequent citations in Warning Letters in the fiscal year 2008 (see our news from 18 February 2009).
The picture is similar in Europe. According to the EMEA analysis of regulatory inspection findings in the centralised procedure, more than 20% of all observations were made in the field of documentation (quality system elements and manufacturing).
This fact proves how important the Batch Record Review is to the authorities. But this review should not only be conducted for the sake of the authorities. It is an important tool for assessing the manufacturing, detecting deviations and initiating process improvements. Learn how this can be done in ECA's 2-day GMP Education Course "Efficient Batch Record Review" in Prague, Czech Republic, on 25 and 26 June 2009.
On behalf of the European Compliance Academy (ECA)