Standard Operating Procedure for Risk Assessment During Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/245/2025 |
| Supersedes | SOP/ELX/245/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for performing structured and systematic risk assessments during the manufacturing of elixir products to proactively identify, evaluate, and control potential risks that may impact product quality, safety, or compliance.
2. Scope
This SOP applies to all risk assessments conducted during process development, batch manufacturing, equipment operation, cleaning, and deviations in the Elixir Department.
3. Responsibilities
- Manufacturing Officer:
- Identify and report potential risks observed during operations.
- QA Officer:
- Facilitate risk assessment sessions, ensure proper documentation, and evaluate mitigation strategies.
- Department Head:
- Approve implementation of control measures and follow-up actions.
4. Accountability
The QA Head is accountable for ensuring that all risk assessments are conducted, documented, and reviewed as per regulatory guidelines (ICH Q9).
5. Procedure
5.1 Risk Assessment Tools
Use one or more of the following tools depending on the nature
of the risk:
- FMEA (Failure Modes and Effects Analysis)
- Fishbone Diagram (Ishikawa)
- 5 Whys Technique
- Risk Ranking and Filtering
5.2 Risk Assessment Initiation
- Initiated when:
- New process/equipment is introduced
- Critical deviation occurs
- Change control is raised
- Periodic review identifies gaps
- QA issues Risk Assessment Form (Annexure-1) and assigns a unique Risk ID.
5.3 Risk Identification
- Cross-functional team identifies failure modes or hazards related to:
- Personnel
- Materials
- Methods
- Machines
- Environment
- List all potential failure points across the manufacturing process flow.
5.4 Risk Evaluation
- Use Risk Priority Number (RPN) = Severity × Occurrence × Detectability.
- Rate each parameter on a scale of 1 (Low) to 5 (High).
- Classify overall risk as:
- Low (RPN 1–25)
- Medium (RPN 26–50)
- High (RPN 51–75)
5.5 Risk Control
- For Medium to High risks, propose and document control measures such as:
- SOP revision
- Additional training
- Equipment calibration/maintenance
- Process validation
- Re-calculate RPN post mitigation to assess effectiveness.
5.6 Documentation and Review
- Complete the Risk Assessment Report and attach supporting evidence.
- Submit to QA for review and closure approval.
- Include finalized risk reports in Product Quality Review (PQR) annually.
6. Abbreviations
- SOP: Standard Operating Procedure
- FMEA: Failure Modes and Effects Analysis
- RPN: Risk Priority Number
- QA: Quality Assurance
7. Documents
- Risk Assessment Form (Annexure-1)
- Risk Register (Annexure-2)
- CAPA Form (if required)
8. References
- ICH Q9 – Quality Risk Management
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- WHO Technical Report Series No. 986, Annex 2
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Risk Assessment Form
| Risk ID | Date | Area | Risk Description | Severity | Occurrence | Detectability | RPN |
|---|---|---|---|---|---|---|---|
| RA/ELX/025 | 11/04/2025 | Mixing | Agitation speed deviation due to control panel fault | 4 | 3 | 3 | 36 |
Annexure-2: Risk Register
| Risk ID | Date | Area | Risk Level | Mitigation Implemented | Status |
|---|---|---|---|---|---|
| RA/ELX/025 | 11/04/2025 | Mixing | Medium | Control panel recalibrated | Closed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP Creation | QA Head |
| 11/04/2025 | 2.0 | Updated to include ICH Q9 framework and risk register | Compliance Enhancement | QA Head |