Risk-Based Inspection (RBI) means the inspector allocates time, depth and sampling to the systems that create the highest patient/product-quality risk and adjusts scope based on risk signals.
Schedule M – Point 5.2 (Quality Control Laboratory Design)
Schedule M 5.2 requires that Quality Control (QC) laboratories are designed appropriately for the operations carried out and that adequate space is provided to avoid mix-ups and cross-contamination. It also requires sufficient and suitable storage for test samples, retained samples, reference standards, reagents and records.
How RBI inspects Schedule M 5.2 in practice (what gets checked)
Because QC results drive batch release decisions, RBI treats poor QC lab design and sample/standard control as a high-impact risk. Typical inspection verification includes:
1) Adequate space to prevent mix-ups
- Are benches, balances, fume hoods, and instruments arranged to prevent simultaneous conflicting activities (e.g., assay prep next to standard prep; open sample handling beside documentation review)?
- Is there clear status segregation for “received / under test / tested / retained / rejected” samples?
- Are dedicated areas defined for high-risk activities (volatile solvents, potent samples, microbiology handling if any crossover)?
2) Cross-contamination control
- Material/personnel flow: do samples move in a controlled route (sample receipt → preparation → testing → retention) without backtracking?
- Cleaning/disinfection: are work surfaces cleaned between products/tests and is this recorded?
- Controls for powders and aerosols: local extraction, closed containers, and waste management so residues don’t spread.
3) Storage space and governance (the core 5.2 requirement)
RBI will check whether storage is sufficient, suitable, and controlled for each category listed in 5.2:
- Test samples & retained samples: labelled, traceable, protected from mix-up; defined conditions (e.g., temperature/humidity/light) where required.
- Reference standards & reagents: segregated (primary vs working), expiry/retest control, preparation labels, storage mapping, and inventory reconciliation.
- Records: secure, retrievable, protected from damage; if electronic, access control and backup discipline.
4) Effectiveness signals
Inspectors often correlate lab design with real events: OOS/OOT errors, repeat tests, contamination events, and deviations. Under RBI, repeated mix-ups or weak segregation typically triggers expanded sampling of raw data, logbooks, and supervisor review practices, because inspection scope and intensity are risk-driven.