Batch Failure

Product rejection due to quality issues

A batch failure, synonymous with product failure, is a rejection of a manufactured product due to failing to meet a specification which may be related to the potency of the product or failure to meet other specifications such as purity. During manufacturing there is a requirement that there is a master production and control record for each drug detailing the exact process, specifications of the product, and requiring operators to detail exact measurements such as weights used in addition to signing off on their participation in the process. If a batch failure occurs there must be an impact assessment performed which investigates the failing batch, batches previously produced, other drug products that may have been affected (such as an API manufactured using an intermediate), and identify the root cause for the failure. ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients includes additional considerations for failures.