Standard Operating Procedure for Semi-Solid Product Storage in Bulk Containers
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/069/2025 |
| Supersedes | SOP/CRM/069/2022 |
| 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) defines the procedure for storing semi-solid cream products in bulk containers. Proper storage ensures the quality, stability, and safety of semi-solid products before they are transferred to packaging or used in further production processes. This SOP ensures that all semi-solid products are stored according to regulatory standards and best practices to prevent contamination, degradation, or any quality deviations.
2. Scope
This SOP applies to all semi-solid cream products stored in bulk containers within the Creams Department. It covers the procedures for receiving, storing, monitoring, and managing bulk containers containing semi-solid products. The scope also includes monitoring environmental conditions such as temperature, humidity, and container integrity.
3. Responsibilities
- Warehouse Personnel: Responsible for receiving and transferring bulk containers of semi-solid products into the storage area, ensuring proper labeling, and monitoring container conditions.
- Quality Control (QC): Responsible for conducting periodic inspections of stored semi-solid products, ensuring they meet quality standards and verifying that storage conditions are compliant with specifications.
- Quality Assurance (QA): Ensures adherence to GMP guidelines for storage and handles the documentation and approval of any deviations.
- Maintenance Team: Responsible for ensuring that storage containers, temperature control systems, and other storage-related equipment are in good working order.
4. Accountability
The Head of Creams Manufacturing is accountable for ensuring the correct implementation of this SOP for all semi-solid product storage operations. The QA Manager is responsible for overseeing the overall compliance with GMP standards and reviewing storage conditions periodically.
5. Procedure
5.1 Pre-Storage Preparation
- Verify that all semi-solid products have passed quality control checks and are cleared for storage.
- Ensure that bulk containers are appropriately labeled with batch numbers, product names, manufacturing dates, and expiration dates.
- Inspect the storage containers for cleanliness and integrity. Ensure that they are free from contamination and suitable for storing semi-solid products.
- Verify that the storage area is clean, dry, and well-ventilated. Confirm that temperature and humidity levels are within the required range for the specific product.
5.2 Transfer to Storage
- Upon clearance, transport bulk containers to the designated storage area using clean equipment, such as forklifts or pallet jacks.
- Ensure that containers are stored in a manner that prevents any physical damage. Place containers in an organized manner to facilitate easy identification and retrieval.
- Store semi-solid products at the appropriate temperature, as specified by the product’s storage requirements. For example, store heat-sensitive products in refrigerated or climate-controlled areas.
5.3 Environmental Monitoring
- Regularly monitor the storage environment for temperature and humidity. Ensure that these are maintained within the specified range for the product’s stability.
- Record the environmental data in the Environmental Monitoring Log (Annexure-1).
- If the storage conditions deviate from the acceptable range, notify the QA team immediately and initiate corrective actions.
5.4 Storage Maintenance
- Inspect storage containers for any signs of leakage, damage, or degradation. Any damaged or compromised containers should be segregated and reported to QA for further investigation.
- Periodically check the integrity of the storage containers. Ensure that seals, lids, or closures are intact and that the products are protected from contamination.
5.5 Documentation and Record Keeping
- Complete all relevant documentation related to the storage of semi-solid products, including batch numbers, storage conditions, and dates.
- Use the Bulk Storage Log (Annexure-2) to document the transfer of semi-solid products to storage.
- Maintain records of environmental monitoring data (temperature and humidity) in the Environmental Monitoring Log (Annexure-1).
- Ensure that all records are reviewed by QA for compliance with SOPs and GMP standards.
5.6 Final Approval for Release
- Once the product has been stored for the required period and no deviations are found, the QA team will review the records and approve the batch for release.
- The release authorization must be documented in the Release Authorization Log (Annexure-3).
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Environmental Monitoring Log
- Annexure-2: Bulk Storage Log
- Annexure-3: Release Authorization 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: Environmental Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Operator | Comments |
|---|---|---|---|---|---|
| 21/01/2026 | 09:00 AM | 22°C | 50% | John Doe | Conditions are within specifications |
Annexure-2: Bulk Storage Log
| Batch Number | Storage Location | Transfer Date | Operator | Storage Conditions |
|---|---|---|---|---|
| 12345 | Storage Room 1 | 21/01/2026 | Jane Smith | Temperature 22°C, Humidity 50% |
Annexure-3: Release Authorization Log
| Batch Number | Authorization Date | Authorized By | Comments |
|---|---|---|---|
| 12345 | 21/01/2026 | John Doe | Approved for release |
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 |