Risk-Based Inspection (RBI) uses quality risk management to decide the frequency, depth and breadth of inspections based on risk to patients and product quality. CDSCO In the CDSCO RBI checklist for sterile utilities, Schedule M point 4.27 and the linked WHO point 4.28 focus on pure steam quality and performance qualification (PQ) of the Pure Steam Generator (PSG)—because failures can directly impact sterilization effectiveness and contamination/endotoxin risk.
4.27 (Schedule M): Pure steam condensate quality
The checklist expects you to confirm whether pure steam (condensate) used in production meets:
- Microbiological specification: not more than 10 cfu/100 mL, and
- IP/BP/USP specifications of WFI (i.e., condensate quality equivalent to WFI quality requirements).
RBI inspection focus (what inspectors verify):
- Where pure steam is used (SIP of tanks/lines, sterilization of product-contact parts, humidification in critical areas, etc.) and whether that use is justified and controlled.
- Sampling plan & locations for condensate: at PSG outlet and at worst-case points-of-use (farthest, lowest flow, most frequently used).
- Routine monitoring records (micro results and relevant physico-chemical tests per pharmacopeia), alert/action handling, deviations, and CAPA effectiveness.
- Data integrity and traceability: every result should link to date/time, sample point, method, analyst, and review.
4.28 (WHO TRS-970): Verify PQ of the PSG
The checklist requires verifying PQ of the PSG (Performance Qualification) and checking supporting records.
RBI inspection focus:
- PQ protocol/report completeness: defined acceptance criteria, worst-case operating conditions, and clear conclusions.
- Evidence the PSG consistently delivers steam quality that results in condensate meeting 4.27 requirements (micro + WFI-quality attributes).
- Control of critical parameters (feedwater quality, generation conditions, traps/condensate removal, distribution design, maintenance).
- Ongoing state of control: calibration, preventive maintenance, change control (e.g., major repair, feedwater change), and periodic requalification triggers.
Common RBI gaps: “specification written but no trending,” missing routine condensate testing, PQ done once but not maintained, and weak deviation/CAPA when results drift—these typically increase inspection depth because they raise sterile-risk directly.