Procedure for Dispensing Materials Using Automated Systems
| Department | Production/Quality Assurance |
|---|---|
| SOP No. | SOP/Ointment/010 |
| 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 guidelines for dispensing raw materials using automated systems in ointment manufacturing. This ensures accuracy, efficiency, traceability, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel responsible for dispensing raw materials using automated dispensing systems. It includes system calibration, material verification, operational steps, and troubleshooting guidelines.
3. Responsibilities
- Production Operator: Operates the automated dispensing system and ensures proper material handling.
- Quality Control (QC) Personnel: Verifies the accuracy and compliance of dispensed materials.
- Production Supervisor: Ensures adherence to operational procedures and troubleshooting protocols.
- Quality Assurance (QA) Officer: Conducts audits and ensures GMP compliance.
- Engineering and IT Support: Maintains the automated dispensing system and provides technical assistance.
4. Accountability
The Production Manager is accountable for ensuring that the automated dispensing system is used correctly and that all operations are recorded properly.
5. Procedure
5.1 Pre-Operation Checks
- Ensure that the automated dispensing system is powered on and functioning correctly.
- Verify that all required raw materials are available and properly labeled.
- Check the system software to ensure the correct batch recipe is uploaded.
- Ensure that the system is calibrated as per the calibration schedule.
5.2 System Calibration
- Perform routine calibration using standard weights.
- Document the calibration details in the Calibration Log.
- Ensure the system meets accuracy standards before proceeding with dispensing.
5.3 Material Verification
- Scan the barcode or manually enter the raw material batch number into the system.
- Ensure that the system matches the material against the approved batch record.
- If a material mismatch is detected, report the issue to QA and halt dispensing.
5.4 Automated Dispensing Process
- Select the appropriate batch recipe in the system.
- Start the dispensing process and monitor the system for any discrepancies.
- Ensure that each dispensed material is within the allowable weight tolerance.
- If a deviation is detected, adjust the batch manually or report to the supervisor.
- Ensure that dispensed materials are properly labeled before moving to the next stage.
5.5 Post-Dispensing Verification
- Cross-check the actual dispensed quantities with the system records.
- Perform sample testing to verify accuracy.
- QA personnel must approve the dispensed batch before proceeding.
5.6 Handling System Errors and Troubleshooting
- If the system malfunctions, follow the troubleshooting guide provided by the manufacturer.
- Escalate any unresolved issues to the Engineering and IT Support team.
- Document all errors and corrective actions taken in the System Error Log.
5.7 Cleaning and Maintenance
- Follow the cleaning protocol after each batch to prevent cross-contamination.
- Use designated cleaning agents and follow system manufacturer guidelines.
- Document all cleaning activities in the Cleaning Log.
5.8 Documentation and Record-Keeping
- Maintain records of all dispensing activities, including batch numbers, operator details, and verification results.
- Ensure that all records are reviewed and approved by QA.
- Retain dispensing records as per regulatory requirements.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ERP – Enterprise Resource Planning
- IT – Information Technology
7. Documents
- Calibration Log (Annexure-1)
- System Error Log (Annexure-2)
- Cleaning Log (Annexure-3)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Calibration Log
| Date | System ID | Standard Weight | Measured Weight | Calibrated By |
|---|---|---|---|---|
| 01/02/2025 | System-01 | 5.000 kg | 5.001 kg | QA Officer |
| 02/02/2025 | System-02 | 3.000 kg | 2.999 kg | QA Officer |
Annexure-2: System Error Log
| Date | System ID | Error Type | Action Taken | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | System-01 | Weight discrepancy | Recalibrated | IT Support |
| 02/02/2025 | System-02 | Software crash | Restarted system | IT Support |
Annexure-3: Cleaning Log
| Date | System ID | Cleaning Agent Used | Cleaned By | Verified By |
|---|---|---|---|---|
| 01/02/2025 | System-01 | IPA 70% | John Doe | QA Officer |
| 02/02/2025 | System-02 | Validated Detergent | Jane Smith | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Approved By |
|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | QA Head |