SOP Guide for Pharma

Creams: SOP for Semi-Solid Product Storage in Bulk Containers – V 2.0

Auditor

Creams: SOP for Semi-Solid Product Storage in Bulk Containers – V 2.0

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

See also  Creams: SOP for Pre-Production Checks in Cream Manufacturing - V 2.0

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.
See also  Creams: SOP for Adjusting Viscosity during Cream Manufacturing - V 2.0

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).
See also  Creams: SOP for Handling Excipient Dispensing in Cream Formulations - V 2.0

6. Abbreviations

7. Documents

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

8. References

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
Exit mobile version