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

1. Verify that all semi-solid products have passed quality control checks and are cleared for storage.
2. Ensure that bulk containers are appropriately labeled with batch numbers, product names, manufacturing dates, and expiration dates.
3. Inspect the storage containers for cleanliness and integrity. Ensure that they are free from contamination and suitable for storing semi-solid products.
4. 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

1. Upon clearance, transport bulk containers to the designated storage area using clean equipment, such as forklifts or pallet jacks.
2. 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.
3. 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

1. Regularly monitor the storage environment for temperature and humidity. Ensure that these are maintained within the specified range for the product’s stability.
2. Record the environmental data in the Environmental Monitoring Log (Annexure-1).
3. If the storage conditions deviate from the acceptable range, notify the QA team immediately and initiate corrective actions.

5.4 Storage Maintenance

1. 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.
2. 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

1. Complete all relevant documentation related to the storage of semi-solid products, including batch numbers, storage conditions, and dates.
2. Use the Bulk Storage Log (Annexure-2) to document the transfer of semi-solid products to storage.
3. Maintain records of environmental monitoring data (temperature and humidity) in the Environmental Monitoring Log (Annexure-1).
4. Ensure that all records are reviewed by QA for compliance with SOPs and GMP standards.

5.6 Final Approval for Release

1. 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.
2. 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

1. Annexure-1: Environmental Monitoring Log
2. Annexure-2: Bulk Storage Log
3. 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