Procedure for Recording Process Observations
| Department | Production/Quality Control (QC)/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/080 |
| 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 standardized method for recording process observations during ointment manufacturing. Proper documentation of observations ensures process control, traceability, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Production, Quality Control (QC), and Quality Assurance (QA) departments responsible for recording and reviewing process observations during manufacturing, filling, and packaging.
3. Responsibilities
- Production Operator: Records observations related to process conditions, material behavior, and equipment performance.
- Production Supervisor: Ensures observations are documented accurately and any deviations are reported.
- Quality Control Analyst: Reviews recorded observations and conducts additional testing if required.
- Quality Assurance (QA) Personnel: Reviews and approves observation records before batch release.
4. Accountability
The Production, QC, and QA Managers are accountable for ensuring that process observations are documented accurately and reviewed as per GMP and regulatory requirements.
5. Procedure
5.1 Equipment and Materials
- Batch Manufacturing Record (BMR)
- Process Observation Log
- Digital or manual recording sheets
- Temperature, pressure, and pH monitoring devices
- Weighing balance
5.2 Types of Process Observations
5.2.1 Raw Material Observations
- Check and record the condition of raw materials (e.g.,
color, texture, packaging integrity).
Verify raw material identity before processing.
Document any discrepancies in supplier specifications.
5.2.2 Mixing Process Observations
- Record temperature, speed, and duration of mixing.
- Observe viscosity changes and phase separation, if any.
- Document any unusual behaviors, such as foaming or clumping.
5.2.3 In-Process Testing Observations
- Document pH, viscosity, and homogeneity test results.
- Record any out-of-specification (OOS) findings and corrective actions taken.
5.2.4 Filling and Packaging Observations
- Monitor and document filling speed, accuracy, and volume deviations.
- Ensure proper labeling and packaging integrity.
- Record any incidents of leaking or mislabeling.
5.3 Process Documentation Requirements
- Observations should be recorded in real time.
- Corrections should be made using a single-line strike-through, with initials and date.
- Any deviations from standard parameters must be reported to the Production Supervisor.
- Final observations should be reviewed and approved before batch release.
5.4 Corrective Actions
- If any deviation is observed, immediately inform the supervisor.
- Document the corrective actions taken in the Process Observation Log.
- Ensure that affected products are held for further inspection before release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- OOS – Out of Specification
7. Documents
- Process Observation Log (Annexure-1)
- Final Batch Observation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q8 – Pharmaceutical Development
- USP <1163> – Quality Assurance in Pharmaceutical Compounding
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 Observation Log
| Date | Batch Number | Process Stage | Observed Parameter | Deviation (if any) | Action Taken | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing | Temperature: 65°C | None | NA | QA Officer |
| 01/02/2025 | OINT-101 | Filling | Volume: 30 g | +0.5 g | Machine adjusted | QA Officer |
Annexure-2: Final Batch Observation Report
| Date | Batch Number | Observation Summary | Corrective Actions | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Minor volume deviation corrected | Machine recalibrated | Approved | QA Head |
| 01/02/2025 | OINT-102 | Temperature fluctuation observed | Verified and within limit | Approved | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |