In a risk-based inspection (RBI), Schedule M – Point 1.5 (Pharmaceutical Quality System) is verified by checking whether your PQS actually ensures consistent product quality across the full lifecycle—not just that SOPs exist. Point 1.5 requires the PQS to ensure controls for product realization, lifecycle knowledge, GMP/GxP-based development, written production/QC operations, defined responsibilities, supplier control, in-process controls/calibration/validation, correct processing and checking, batch certification before sale, outsourced activity control, storage/distribution controls, self-inspection, trending and deviation prevention, change control, product quality reviews, state of control/continual improvement, QRM, and robust deviation/defect investigation with CAPA effectiveness.
How RBI is performed (what inspectors test):
- Follow the risk: Inspectors start with your highest-risk products/processes (sterile/aseptic steps, potent products, high complaint/recall history) and trace whether PQS controls prevented or quickly detected failures.
- Evidence over statements: They sample real records—batch files, deviation logs, CAPA effectiveness checks, change controls, validation status, supplier qualification files, and product quality reviews—and verify they match the written system required by 1.5.
- Key “stress tests”:
- Batch release discipline: proof that no batch is supplied before authorized certification and review is complete.
- Supplier/supply-chain assurance: approved suppliers, incoming verification, and traceability for each delivery.
- State of control: trending of IPCs, utilities, EM (if applicable), OOS/OOT, and recurring deviations driving preventive actions.
- Change control: prospective assessment, approvals before implementation, and post-change effectiveness review.
- Deviation/CAPA quality: root-cause depth, batch impact assessment, and demonstrated CAPA effectiveness.
Common RBI red flags: “paper PQS” with weak trend reviews, repeated deviations without effective CAPA, uncontrolled supplier changes, and changes implemented before approval.