Standard Operating Procedure for Dispensing Cream Batches into Intermediate Storage
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/071/2025 |
| Supersedes | SOP/CRM/071/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
This Standard Operating Procedure (SOP) describes the process for dispensing cream batches into intermediate storage containers. The goal is to ensure that cream batches are transferred efficiently and safely to intermediate storage without contamination or degradation. This SOP ensures that the correct procedures are followed to maintain the quality and stability of cream products in preparation for further processing or packaging.
2. Scope
This SOP applies to the dispensing of cream batches into intermediate storage containers within the Creams Department. It includes procedures for preparing containers, transferring cream batches, and ensuring that the storage conditions are appropriate to maintain the quality of the product.
3. Responsibilities
- Production Team: Responsible for ensuring that cream batches are dispensed accurately into intermediate storage containers and that all procedures are followed as per this SOP.
- Quality Control (QC): Responsible for verifying that the dispensed cream batches meet quality standards and that the containers are properly sealed and labeled.
- Quality Assurance (QA): Ensures that all dispensing procedures are followed according to GMP standards and that the documentation is complete and compliant.
- Warehouse Personnel: Responsible for storing the intermediate containers in the appropriate storage conditions and maintaining the integrity of the product during this phase.
4. Accountability
The Head of Production is responsible for overseeing the dispensing process and ensuring adherence to this SOP. The QA Manager is responsible for verifying compliance with GMP and for reviewing records of all dispensing operations.
5. Procedure
5.1 Pre-Dispensing Preparation
- Ensure that the cream batch is complete, mixed thoroughly, and approved for dispensing by QC.
- Verify that the intermediate storage containers are clean, dry, and free of contaminants. Check that containers are the correct size and type for the batch being dispensed.
- Inspect the storage containers for proper labeling and ensure that they are clearly marked with the required batch information.
- Verify that the dispensing equipment, such as pumps or valves, is clean and calibrated.
5.2 Dispensing Cream into Intermediate Storage Containers
- Ensure that the dispensing equipment is connected securely to the storage container and that the cream batch is ready for transfer.
- Slowly begin dispensing the cream batch into the intermediate storage containers. Monitor the flow to prevent overfilling or spillage.
- While dispensing, periodically check the consistency of the cream to ensure it is homogeneous and meets quality specifications.
- After dispensing, ensure that the container is properly sealed to prevent contamination. Label the container with the necessary batch and storage information.
- If there is any leftover cream after dispensing, ensure it is transferred to a clean, labeled container, and the remaining amount is documented.
5.3 Post-Dispensing Checks
- Once dispensing is complete, inspect the filled containers for any defects, such as leaks or improperly sealed lids.
- Perform a visual inspection to ensure that the cream is uniform in consistency and color within the containers.
- Record the batch number, quantity dispensed, and any deviations observed during the dispensing process in the Dispensing Log (Annexure-1).
- Any deviations must be documented in the Deviation Report Form (Annexure-2), and corrective actions must be taken if required.
5.4 Environmental Monitoring
- Ensure that the intermediate storage containers are placed in the appropriate storage conditions (e.g., temperature, humidity) according to product specifications.
- Monitor the storage area regularly to ensure that conditions remain within acceptable ranges. Record temperature and humidity levels in the Environmental Monitoring Log (Annexure-3).
5.5 Documentation and Record Keeping
- Complete the Dispensing Log (Annexure-1) with all relevant details, including batch numbers, quantities dispensed, operator names, and any deviations.
- Ensure that all records are reviewed and signed by the appropriate personnel to verify compliance with the SOP.
5.6 Final Approval
- The QA team must review all dispensing records and ensure that the batch has been dispensed correctly into intermediate storage.
- If the dispensing process meets all specifications, the batch is approved for the next stage of processing or packaging.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Dispensing Log
- Annexure-2: Deviation Report Form
- Annexure-3: Environmental Monitoring Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Dispensing Log
| Batch Number | Quantity Dispensed | Operator | Dispensing Date | Storage Location | Comments |
|---|---|---|---|---|---|
| 12345 | 500 kg | John Doe | 21/01/2026 | Storage Room 1 | No issues |
Annexure-2: Deviation Report Form
| Deviation Description | Time | Batch Number | Operator | Immediate Action |
|---|---|---|---|---|
| Spillage during dispensing | 10:30 AM | 12345 | Jane Smith | Cleaned up and adjusted dispensing procedure |
Annexure-3: Environmental Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Operator | Comments |
|---|---|---|---|---|---|
| 21/01/2026 | 11:00 AM | 22°C | 55% | John Doe | Conditions are stable |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |