In a risk-based inspection (RBI), Schedule M point 39.8 (sterile products checklist) focuses on one of the highest contamination-risk activities: gowning to enter the sterile area, and it specifically requires inspectors to review the gowning procedure and verify entry/exit records. CDSCO
RBI treats gowning as critical because people are the largest source of viable and non-viable contamination in aseptic operations. A weak gowning system can compromise Grade B/A conditions, create recurring environmental monitoring excursions, and increase sterility failure risk.
What inspectors check under 39.8 (depth-based on risk):
- Documented SOP for sterile entry: stepwise gowning sequence (hand wash → hand disinfection → donning order), defined change rooms (black/grey/white as applicable), and controls to prevent “backtracking” or wrong-direction movement.
- Gown set specification and control: approved gown components (hood, mask, sterile coverall, sterile gloves, sterile boots), material type, size control, integrity checks (tears/holes), and rules for replacing damaged garments immediately.
- Sterilization and storage of sterile garments: validated sterilization method (e.g., autoclave/gamma), packaging integrity, expiry/hold time, and protected storage in the final change room.
- Gloving discipline: disinfection frequency, when to change outer gloves, and avoidance of non-sterile contact after final gowning.
- “Entry/exit records” verification: logbooks/electronic access showing who entered, when, and for what purpose; reconciliation against production/EM data; and confirmation that unauthorized entry is prevented.
- Training and qualification: initial and periodic gowning qualification (including observation), documented re-training after failures, and linkage to personnel monitoring results.
Typical RBI red flags: missing or incomplete entry/exit logs, operators skipping gowning steps during “urgent interventions,” repeated personnel EM failures without CAPA, reused/over-aged sterile garments, and unclear separation between pre-gown and sterile-gown zones.