1Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The monitoring procedures for microbial and/or environmental conditions were inadequate.
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Other quality system
The assessment to release finished products was inadequate.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Stability and storage
Reworked or reprocessed drug lots were not included in the ongoing stability program.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
