Procedure for Recording and Investigating Non-Conformance Reports
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/163 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for recording and investigating non-conformance reports (NCRs) in pharmaceutical manufacturing. Proper documentation and investigation of non-conformances ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements while maintaining product quality.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for identifying, documenting, investigating, and resolving non-conformances observed in materials, processes, equipment, and final products.
3. Responsibilities
- Production Supervisor: Identifies non-conformances and initiates NCRs.
- QC Analyst: Evaluates non-conformances related to product quality and testing.
- QA Officer: Reviews NCRs and initiates investigations.
- CAPA Coordinator: Implements corrective and preventive actions.
- QA Manager: Approves NCR resolutions and ensures compliance.
4. Accountability
The QA and Production Managers are accountable for ensuring that all non-conformance reports are documented, investigated, and resolved in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Identification of Non-Conformances
Non-conformances can occur at various stages of manufacturing and include:
- Material Non-Conformance: Raw materials or packaging materials that do not meet specified standards.
- Process Non-Conformance: Deviations from standard operating procedures (SOPs) in manufacturing.
- Product Non-Conformance: Finished products failing to meet quality standards.
- Equipment Non-Conformance: Malfunctions or deviations in equipment performance.
- Documentation Non-Conformance: Errors or omissions in records and logbooks.
5.2 Initiating a Non-Conformance Report (NCR)
- Any personnel identifying a non-conformance must report it to the **Production Supervisor or QA Officer** immediately.
- An **NCR Form** must be completed, capturing the following details:
- Date and time of occurrence.
- Location and process step affected.
- Description of the non-conformance.
- Immediate actions taken.
- Person reporting the issue.
- The NCR form must be submitted to QA within **24 hours** of identification.
5.3 Investigation of Non-Conformance
- QA must initiate an **investigation within 48 hours** of receiving an NCR.
- Investigation steps include:
- Reviewing batch records and process logs.
- Conducting interviews with personnel involved.
- Analyzing raw material and finished product test results.
- Inspecting equipment and calibration records.
- The **Root Cause Analysis (RCA)** must be documented in the **NCR Investigation Report.**
- Critical non-conformances must be escalated to senior management.
5.4 Corrective and Preventive Action (CAPA)
- Based on the investigation findings, a **CAPA Plan** must be developed.
- Corrective Actions:
- Immediate measures to correct the identified non-conformance.
- Batch rejection or product recall if necessary.
- Training of personnel if human error is identified.
- Preventive Actions:
- Updating SOPs and work instructions.
- Enhancing equipment calibration and maintenance programs.
- Implementing additional quality control checks.
- The CAPA plan must be reviewed and approved by the **QA Manager.**
5.5 Implementation and Verification of CAPA
- The CAPA Coordinator must track the implementation of corrective and preventive actions.
- A **CAPA Effectiveness Check** must be conducted **one month after implementation.**
- QA must verify that the non-conformance has not recurred.
5.6 Closure and Documentation of NCRs
- QA must ensure all NCRs are properly documented and closed within the required time frame.
- NCR reports and CAPA records must be reviewed **monthly.**
- All NCRs must be archived for **a minimum of 5 years.**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- NCR – Non-Conformance Report
- CAPA – Corrective and Preventive Action
- RCA – Root Cause Analysis
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Non-Conformance Report Template (Annexure-1)
- CAPA Implementation Log (Annexure-2)
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO Guidelines on Deviation and CAPA Management
- US FDA Guidance on CAPA Implementation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Non-Conformance Report Template
| Date | Process Step | Non-Conformance Description | Reported By | QA Review |
|---|---|---|---|---|
| 02/02/2025 | Mixing Process | Temperature exceeded by 2°C | John Doe | Reviewed |
Annexure-2: CAPA Implementation Log
| Date | CAPA Action | Responsible Person | Completion Date | Effectiveness Check |
|---|---|---|---|---|
| 02/02/2025 | Temperature alarm system installed | Jane Smith | 05/02/2025 | Verified |