SOP for Deviation Management during Analytical Method Development Activities
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/031/2025 |
| Supersedes | SOP/AMD/031/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 19/05/2025 |
| Effective Date | 20/05/2025 |
| Review Date | 19/05/2026 |
1. Purpose
This SOP describes the procedure for managing deviations that occur during analytical method development activities. It ensures proper identification, documentation, investigation, impact assessment, and closure in compliance with current Good Manufacturing Practices (cGMP) and quality system requirements.
2. Scope
This SOP applies to all deviations observed during analytical method development activities including experimental errors, procedural lapses, equipment malfunctions, and data anomalies within the AMD department.
3. Responsibilities
- Analytical Scientist: Identifies and documents deviations immediately; initiates preliminary investigation.
- Team Lead: Reviews deviation details and supports root cause analysis and CAPA recommendations.
- QA: Reviews, categorizes, and approves the deviation record; ensures compliance and closure.
- Head – AMD: Approves deviation disposition and oversees any required rework, retraining, or documentation changes.
4. Accountability
The Head of AMD is accountable for ensuring timely documentation, investigation, and resolution of all method development-related deviations in accordance with the site quality system and applicable regulatory guidelines.
5. Procedure
5.1 Deviation Identification
- Deviations may include:
- Missed procedural steps (e.g., wrong pH buffer used)
- Instrument malfunction during run
- Improper documentation
- Outlier data points with unexplained causes
- Analyst must report and document the deviation using Annexure-1: Deviation Reporting Form within 24 hours of occurrence.
5.2 Deviation Classification
- QA and Team Lead jointly classify the deviation as:
- Minor: No significant impact on method outcome or GMP compliance.
- Major: Affects critical parameters or may lead to rework.
- Critical: Affects data integrity, regulatory filing, or results in potential non-compliance.
- Classification to be recorded in Annexure-2: Deviation Classification Log.
5.3 Investigation and Root Cause Analysis
- Use structured RCA tools (Fishbone Diagram, 5 Whys).
- Identify whether deviation arose from:
- Human error
- Equipment failure
- Documentation issue
- Material or reagent problem
- Record findings in Annexure-3: Root Cause Investigation Form.
5.4 Impact Assessment
- Evaluate the impact on:
- Development outcomes
- Validation readiness
- Regulatory submission timelines
- Define impact level (Low/Medium/High) and document in Annexure-4: Impact Assessment Sheet.
5.5 Corrective and Preventive Actions (CAPA)
- CAPA should address both immediate correction and long-term prevention.
- Actions may include:
- Re-training
- Instrument maintenance
- Document revision
- Procedural changes
- Document in Annexure-5: CAPA Implementation Tracker.
5.6 Deviation Closure
- QA to review investigation and CAPA implementation.
- If acceptable, deviation is marked “Closed” and documented in Annexure-6: Deviation Closure Record.
- Closed deviation records to be archived with traceable index for audit readiness.
6. Abbreviations
- AMD: Analytical Method Development
- CAPA: Corrective and Preventive Action
- QA: Quality Assurance
- RCA: Root Cause Analysis
- GMP: Good Manufacturing Practices
7. Documents
- Deviation Reporting Form – Annexure-1
- Deviation Classification Log – Annexure-2
- Root Cause Investigation Form – Annexure-3
- Impact Assessment Sheet – Annexure-4
- CAPA Implementation Tracker – Annexure-5
- Deviation Closure Record – Annexure-6
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO TRS 996 – Quality Risk Management
- US FDA 21 CFR Part 211 – Subpart J: Records and Reports
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Reporting Form
| Date | Analyst | Method Code | Description of Deviation |
|---|---|---|---|
| 12/05/2025 | Rajesh Kumar | AMD/UV/062 | Used wrong buffer concentration in mobile phase |
Annexure-2: Deviation Classification Log
| Deviation ID | Type | Classification | Remarks |
|---|---|---|---|
| DEV/AMD/2025/017 | Procedural | Major | Deviation from protocol |
Annexure-3: Root Cause Investigation Form
| Cause Identified | Tool Used | RCA Summary |
|---|---|---|
| Human Error | 5 Whys | Untrained staff used incorrect stock |
Annexure-4: Impact Assessment Sheet
| Impact Area | Level | Justification |
|---|---|---|
| Method Development Outcome | Medium | Trial required repetition |
Annexure-5: CAPA Implementation Tracker
| CAPA Action | Owner | Due Date | Status |
|---|---|---|---|
| Re-training on buffer preparation | Sunita Reddy | 15/05/2025 | Completed |
Annexure-6: Deviation Closure Record
| Deviation ID | Closure Date | Closed By | QA Approval |
|---|---|---|---|
| DEV/AMD/2025/017 | 17/05/2025 | Vinay Pawar | Approved |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Expanded impact assessment and included RCA formats | Audit recommendation |