Frequently Asked Questions

QA must be an independent function, separate from production. The head of QA has the authority to approve or reject any material, intermediate, or finished product. QA is responsible for reviewing production records, investigating deviations, approving SOPs, conducting stability studies, and overseeing the self-inspection program. QA's core responsibilities cannot be delegated to production or other departments.

Under Revised Schedule M, all OOS investigations must be completed within 30 days of the OOS result being identified. The investigation follows a two-phase approach: Phase 1 is the initial laboratory investigation (checking for obvious errors), and Phase 2 is the comprehensive investigation if Phase 1 doesn't identify the cause. The batch cannot be released until the investigation is satisfactorily completed.

While certain testing activities may be outsourced to approved contract laboratories, the overall QC responsibility cannot be delegated. The QC department must maintain oversight of all outsourced testing, including audit rights of contract labs. Similarly, the QA department's core regulatory responsibilities for batch release and document review cannot be outsourced.

Ongoing stability studies must be conducted to monitor product quality throughout its shelf life. This includes testing at defined intervals using validated methods. Results must be reviewed by QA and compared against specifications. Any out-of-trend results must be investigated. Stability data forms the basis for assigned shelf life and storage conditions.