PDA Technical Glossary

An established microbial or airborne particle level that, when exceeded, indicates a process is outside of its normal operating range. A response to such an excursion should involve a documented investigation and corrective actions based on the results of that investigation. (TR13) An established microbial or non-viable particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (TR22) An established microbial or airborne particle level for environmental, water or gas monitoring that, when exceeded, indicates that a facility process is outside of its normal operating range. The response to such an excursion involves a documented investigation and corrective actions based on the results of that investigation. The prescribed action level is often specified in guidance or standards relating to environmental monitoring and water quality. (TR69) An established microbial or nonviable particle level for environmental, water, or gas monitoring that, when exceeded, indicates a facility or process is outside of its normal operating range. The response to such an excursion may involve a documented investigation and corrective actions based on the results. The prescribed action level is often specified in guidances or standards relating to environmental monitoring and water quality (3-6). (TR88)

An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action but typically requires follow-up investigation. (TR13) (TR22) (TR69) An established level that, when exceeded, is giving an early warning of a potential drift from normal operating conditions; while not necessarily grounds for definitive corrective action, it typically requires follow-up review. (TR 60) An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action, but typically requires follow-up investigation (3, 4, 7). (TR88)

An investigatory team, comprising representatives including QCU microbiologists, manufacturing, engineering, and maintenance personnel, and other appropriate SMEs, with the purpose of conducting a manufacturing investigation. (TR88)

Describes the processes and activities that need to take place to characterize and monitor the quality of the environment. (TR70) Monitoring for nonviable particulates and/or microorganisms where the result meets or exceeds the alert and/or action level or limit. (TR88)

A self-evident documented mistake that will bring the validity of a laboratory test into question. (TR88)

A self-evident documented mistake that will bring the manufacturing process into question. (TR88)

Determination of how a product failure may extend an investigation “to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy” (10). (TR88)

Laboratory test that, as a result of the laboratory (Phase I) investigation, did not meet the test method requirements and whose results would not be deemed valid. This may also apply to a test which was aborted (e.g. breakdown of isolator during sterility testing). (TR88)

Any unexplained deviation or result that failed to meet set levels for environmental monitoring and other utilities. (TR88)

Any unexplained deviation or the failure of a pharmaceutical ingredient, drug substance, or drug product batch to meet any of its regulatory-release and shelf-life specifications. (TR88)

The percentage of the time that a manufacturing process step, batch record, or in-process or laboratory test is successfully completed on the first attempt. (TR88)