Procedure for Monitoring Real-Time Process Parameters
| Department | Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/198 |
| 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 monitoring real-time process parameters during the manufacturing of ointments to ensure process consistency, product quality, and regulatory compliance.
2. Scope
This SOP applies to manufacturing, production, engineering, and quality assurance personnel responsible for monitoring and recording real-time process parameters such as temperature, mixing speed, pressure, and viscosity.
3. Responsibilities
- Production Supervisor: Ensures process parameters are monitored and recorded accurately.
- Process Operator: Continuously monitors and adjusts process parameters in real time.
- QA Officer: Reviews recorded data and verifies adherence to GMP standards.
- QC Analyst: Validates process parameters against product quality specifications.
- Engineering Team: Ensures calibration and functionality of monitoring equipment.
4. Accountability
The Head of Manufacturing is accountable for ensuring that real-time process monitoring is performed in compliance with GMP and regulatory guidelines.
5. Procedure
5.1 Identifying Critical Process Parameters (CPPs)
- Identify key process parameters such as:
- Temperature
- Mixing Speed
- Pressure
- Viscosity
- Document CPPs in the **Process Parameter Identification Log (Annexure-1).**
5.2 Monitoring and Recording Real-Time Data
- Use automated sensors and manual checks to monitor process parameters.
- Record real-time data at specified intervals in
the **Real-Time Process Monitoring Log (Annexure-2).**
5.3 Analyzing Data for Process Deviations
- Compare recorded values with predefined acceptable limits.
- Identify trends or deviations and take corrective actions.
- Maintain data in the **Process Deviation Analysis Report (Annexure-3).**
5.4 Corrective Actions for Out-of-Specification (OOS) Events
- Investigate and document any deviations in real-time parameters.
- Implement corrective actions and verify effectiveness.
- Record actions taken in the **Corrective Action Log (Annexure-4).**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CPP – Critical Process Parameters
- OOS – Out of Specification
7. Documents
- Process Parameter Identification Log (Annexure-1)
- Real-Time Process Monitoring Log (Annexure-2)
- Process Deviation Analysis Report (Annexure-3)
- Corrective Action Log (Annexure-4)
8. References
- FDA Guidance on Process Monitoring
- ICH Q8 – Pharmaceutical Development Guidelines
- WHO GMP Guidelines for Process Control
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Process Parameter Identification Log
| Date | Batch No. | Parameter | Acceptable Range | QA Approval |
|---|---|---|---|---|
| 06/02/2025 | OINT-8001 | Temperature | 45°C – 50°C | Approved |
Annexure-2: Real-Time Process Monitoring Log
| Date | Batch No. | Time | Parameter | Observed Value | QA Approval |
|---|---|---|---|---|---|
| 06/02/2025 | OINT-8001 | 10:00 AM | Temperature | 46.5°C | Approved |
Annexure-3: Process Deviation Analysis Report
| Date | Batch No. | Deviation Observed | Possible Cause | QA Approval |
|---|---|---|---|---|
| 06/02/2025 | OINT-8001 | Pressure Drop | Leak in pipeline | Approved |
Annexure-4: Corrective Action Log
| Date | Batch No. | Corrective Action Taken | Verified By | QA Approval |
|---|---|---|---|---|
| 06/02/2025 | OINT-8001 | Pipeline repaired | QA Officer | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 06/02/2025 | 2.0 | Added real-time monitoring methodology | Process Improvement | QA Head |
| 01/01/2024 | 1.0 | Initial SOP | New SOP Implementation | QA Head |