Risk Based Inspection (RBI) increases inspection depth where patient-risk is highest. In packaging, the biggest risks are mix-ups, wrong label/expiry, and cross-contamination—so RBI heavily focuses on line clearance discipline and its records.
Schedule M – Point 34.4 (What it requires)
Schedule M checklist point 34.4 asks: How line clearance is performed and whether line clearance records are maintained as per an appropriate checklist.
This aligns with Schedule M’s core GMP requirement that before any packaging operation begins, checks must confirm the equipment and work station are clear of previous products/documents/materials not required, and that equipment is clean and suitable for use—and these checks must be recorded.
Revised Schedule M also states that packaging areas/lines/printing machines must be clean and free from products/materials/spillages, and that line clearance is performed using a checklist and recorded.
What RBI verifies on the shop floor (typical evidence)
- Line clearance checklist quality
Inspectors check whether the checklist is product/line specific, includes photos or “golden samples” where needed, and covers: removal of previous batch components, printed materials, overprint settings, code/label verification, document removal, bin/trolley clearance, and segregation status. - Two-stage clearance (before + after)
RBI looks for evidence of clearance before start and often after completion/changeover, consistent with the expectation to carefully examine packaging area/equipment to ensure line clearance around packaging operations. - Record integrity (ALCOA+ behaviour)
Records should be contemporaneous, signed/dated, legible, and traceable to batch number, line, time, and verifier. If electronic, access control and audit trails should prevent back-dating or deletion. - Independent verification (QA/IPQA role)
RBI commonly checks whether a second person (often IPQA) independently verifies critical clearance points (printed material, coding, batch details, reconciliation readiness). - Effectiveness signals
Inspectors correlate clearance records with deviations/complaints/returns/recalls related to labelling or mix-ups. Repeated packaging incidents usually trigger deeper sampling of 34.4 compliance.
Common RBI observations: checklist exists but not followed, missing attachments in BPR, weak control of printed leftovers, and clearance done “by signature only” without physical verification.