Schedule M – Point 8.7 (Water & Steam Systems for sterile manufacturing) requires that there is a written procedure and program for sanitation of the different water systems—covering storage tanks, distribution lines, pumps and related equipment—and that sanitation records are maintained.
How this becomes a “high-priority system” in Risk-Based Inspection (RBI)
In RBI, the inspector gives more depth and sampling to systems that can directly impact patient safety. Water used in sterile manufacturing is a critical utility: if sanitation is weak, microbial growth, biofilm formation, endotoxin risk, and contamination events can occur, affecting product quality and sterility assurance. Because water systems are complex (loops, dead legs, multiple points-of-use), RBI typically treats sanitation control as a high-risk area, especially where Water for Injection (WFI) or purified water is used for final rinses, disinfectant preparation, or product-contact activities. IPA Pharma
What RBI inspectors usually verify for compliance with 8.7
- Documented sanitation strategy (SOP + program):
- Defined sanitation method(s): hot water/heat, steam, ozone, chemical sanitants, UV support (as applicable).
- Frequency and rationale (risk-based: usage pattern, historical trends, seasonal risks, system design).
- Clear parameters (temperature, hold time, concentration, flow, contact time) and responsibilities.
- Execution evidence (records):
- Sanitization logs for each loop/tank (date, method, key parameters achieved, operator, verification sign-off).
- Equipment status controls to prevent use during/after failed sanitization (QA/QC involvement where required).
- Deviation handling when parameters are not met and documented CAPA.
- System design & “worst points”:
- Controls for dead legs, low-flow areas, vents/filters, tank spray balls, return loop turbulence, and point-of-use hygiene.
- Change control for any modifications that could affect microbial control.
- Link to monitoring & trending:
While 8.7 is sanitation, RBI checks that sanitation outcomes are supported by the microbiological monitoring program (next clause 8.8) and that alert/action trends drive program updates.
Typical RBI observations (common gaps)
- “SOP exists” but no defined program/frequency or inadequate rationale.
- Sanitization done but critical parameters not recorded (only signatures).
- Repeated micro alerts without program improvement (no trending/review).
- Poor control of tank vents/filters or point-of-use practices leading to recontamination.
A strong 8.7 implementation shows controlled, verified, trended sanitation—not just periodic cleaning.