Risk-Based Inspection (RBI) increases inspection depth for high-risk utilities like water systems, using a risk-based approach that considers facility/product risk and compliance history. CDSCO
Schedule M – Point 8.8 (Microbiological monitoring of water)
Schedule M 8.8 requires that there is a written microbiological monitoring program for different types of water. The results must justify the frequency of sampling and testing, and any deviation from prescribed limits must be investigated with corrective action taken.
Why 8.8 is high-focus in RBI
Water is a “hidden ingredient” used for product manufacture, cleaning, rinsing, and utilities. If microbial control drifts, risks include biofilm formation, contamination of equipment/product, endotoxin risk (where applicable), and repeated deviations—so RBI treats weak monitoring programs as a strong signal of poor utility control.
What RBI inspectors typically verify for 8.8
- Program design and scope
- Water categories covered (e.g., potable/PW/WFI or other site-defined types) and where each is used.
- Sampling points include generation, storage, loop return, and points of use.
- Sampling plan justified by data (core 8.8 intent)
- Frequency is not arbitrary: it is supported by historical results/trends as Schedule M expects.
- Inspectors check whether sampling includes “worst-case” points (farthest/lowest flow/most stagnant).
- Alert/action limits, trending, and review
WHO’s sterile GMP guidance expects ongoing microbial monitoring, alert levels based on qualification data, periodic reassessment, and trend review to detect deterioration; sampling should cover outlets/points of use at defined intervals. World Health Organization - Deviation handling and corrective action
- Evidence of investigations (root cause, impact assessment on batches/processes), sanitation actions, and effectiveness checks—because 8.8 explicitly requires investigation and corrective action when limits are exceeded.
Common RBI observations (typical gaps)
- “Program exists” but frequency is copied from SOP without trend justification.
- Missing/wrong sampling points (only tank sampled, not PoU).
- Repeated excursions with weak investigations (“re-sample and close”).