ABSTRACT

All process and environmental control activities must be maintained and documented on a daily basis for aseptic processing operations. Review of all batch records and data is required to assure compliance with written procedures, operating parameters, and product specifications before final release of product for a given manufacturing cycle. Information in the batch record documentation includes data relating to in-process testing, environmental control, personnel monitoring, utilities [e.g., HVAC, water for injections (WFI), and steam], equipment functioning (e.g., alarms, integrity of filters), and deviations (5).