Standard Operating Procedure for Risk-Based Inspection Planning in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/192/2025 |
| Supersedes | SOP/API/192/2022 |
| Page No. | Page 1 of 16 |
| Issue Date | 14/04/2025 |
| Effective Date | 16/04/2025 |
| Review Date | 14/04/2026 |
1. Purpose
To define a standardized approach for planning inspections based on risk levels associated with materials, equipment, processes, and systems within the API manufacturing facility, thereby ensuring effective monitoring and compliance in line with ICH Q9 and cGMP requirements.
2. Scope
This SOP is applicable to the Quality Assurance (QA) team responsible for internal inspections, audits, and monitoring activities
across various departments involved in API manufacturing. It covers routine inspections, targeted risk-based assessments, and trend-based inspections.
3. Responsibilities
- QA Team: Conducts risk assessment, prepares inspection calendar, and performs inspections.
- Department Heads: Cooperate during inspections, provide required records, and implement corrective actions.
- QA Manager: Reviews risk scores and inspection schedules, approves plans, and ensures follow-up.
4. Accountability
The Head of Quality Assurance is accountable for approving the risk-based inspection plan and ensuring effective execution of the inspection strategy as per regulatory and quality system requirements.
5. Procedure
5.1 Preparation of Inspection Calendar
- QA shall prepare an Annual Risk-Based Inspection Calendar (Annexure-1) by December for the next calendar year.
- The calendar shall consider:
- Risk priority of systems/processes
- Past inspection findings
- Criticality of operations
- Changes introduced or deviations reported
5.2 Risk Assessment Methodology
- Each process, area, or system shall be assessed using the Risk Scoring Template (Annexure-2) based on:
- Severity (S): Potential impact on product quality or compliance
- Occurrence (O): Likelihood of failure or deviation
- Detection (D): Probability of detecting a failure before release
- Risk Priority Number (RPN) = S × O × D
- Risk levels shall be categorized as:
- High: RPN ≥ 150
- Medium: 75 ≤ RPN < 150
- Low: RPN < 75
5.3 Inspection Planning and Frequency
- High-risk areas – Inspect at least once per quarter
- Medium-risk areas – Inspect once in six months
- Low-risk areas – Inspect once annually
- All inspections shall be unannounced to promote preparedness and routine compliance.
5.4 Execution of Inspection
- QA shall issue a Risk-Based Inspection Checklist (Annexure-3) tailored for the area/process being reviewed.
- Inspectors shall review:
- Compliance with SOPs
- Housekeeping and documentation practices
- Condition of equipment and infrastructure
- In-process control and data recording
- Observations shall be recorded in the Inspection Observation Log (Annexure-4).
5.5 Reporting and CAPA
- Post-inspection, QA shall prepare a Risk-Based Inspection Report (Annexure-5) within 5 working days.
- Departments shall respond with CAPA within 10 working days using the CAPA Response Form (Annexure-6).
- QA shall review CAPA implementation and close the report formally.
5.6 Trending and Review
- All RPN scores and findings shall be reviewed quarterly for trend identification using the Inspection Trending Log (Annexure-7).
- Emerging trends or repetitive findings may trigger reclassification of risk and increase in inspection frequency.
6. Abbreviations
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
- RPN: Risk Priority Number
- SOP: Standard Operating Procedure
- ICH: International Council for Harmonisation
7. Documents
- Annual Risk-Based Inspection Calendar (Annexure-1)
- Risk Scoring Template (Annexure-2)
- Risk-Based Inspection Checklist (Annexure-3)
- Inspection Observation Log (Annexure-4)
- Inspection Report Template (Annexure-5)
- CAPA Response Form (Annexure-6)
- Inspection Trending Log (Annexure-7)
8. References
- ICH Q9 – Quality Risk Management
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 211 – Current Good Manufacturing Practice
- EU GMP Chapter 9 – Self Inspection
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Annual Risk-Based Inspection Calendar
| Area | Risk Level | Planned Inspection Frequency | Responsible |
|---|---|---|---|
| API Synthesis Room | High | Quarterly | QA |
Annexure-2: Risk Scoring Template
| Parameter | Score (1-10) | Remarks |
|---|---|---|
| Severity | 8 | Critical process step |
| Occurrence | 7 | Previous deviation reported |
| Detection | 5 | Moderate controls in place |
| RPN | 280 | |
Annexure-3: Risk-Based Inspection Checklist
| Item | Status (Y/N) | Comments |
|---|---|---|
| Equipment Calibration Verified | Yes | Compliant |
| Area Cleanliness | No | Dust observed on panels |
Annexure-4: Inspection Observation Log
| Date | Area | Observation | Category | Inspector |
|---|---|---|---|---|
| 12/04/2025 | Drying Room | Unauthorized tool present | Major | QA Executive |
Annexure-5: Inspection Report Template
| Inspection Date | Area | Summary | Inspector |
|---|---|---|---|
| 13/04/2025 | Solvent Recovery | 2 minor, 1 major observation | QA |
Annexure-6: CAPA Response Form
| Observation No. | CAPA Description | Responsible | Target Date |
|---|---|---|---|
| OBS-2025-12 | Replace damaged hose line | Maintenance | 20/04/2025 |
Annexure-7: Inspection Trending Log
| Month | Area | Observation Count | Repetitive Observations | Trend |
|---|---|---|---|---|
| March 2025 | Granulation | 4 | 2 | Stable |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 14/04/2025 | 2.0 | Integrated Risk Scoring and RPN classification | ICH Q9 Alignment | QA Head |