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

1. Ensure that the cream batch is complete, mixed thoroughly, and approved for dispensing by QC.
2. 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.
3. Inspect the storage containers for proper labeling and ensure that they are clearly marked with the required batch information.
4. Verify that the dispensing equipment, such as pumps or valves, is clean and calibrated.

5.2 Dispensing Cream into Intermediate Storage Containers

1. Ensure that the dispensing equipment is connected securely to the storage container and that the cream batch is ready for transfer.
2. Slowly begin dispensing the cream batch into the intermediate storage containers. Monitor the flow to prevent overfilling or spillage.
3. While dispensing, periodically check the consistency of the cream to ensure it is homogeneous and meets quality specifications.
4. After dispensing, ensure that the container is properly sealed to prevent contamination. Label the container with the necessary batch and storage information.
5. 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

1. Once dispensing is complete, inspect the filled containers for any defects, such as leaks or improperly sealed lids.
2. Perform a visual inspection to ensure that the cream is uniform in consistency and color within the containers.
3. Record the batch number, quantity dispensed, and any deviations observed during the dispensing process in the Dispensing Log (Annexure-1).
4. Any deviations must be documented in the Deviation Report Form (Annexure-2), and corrective actions must be taken if required.

5.4 Environmental Monitoring

1. Ensure that the intermediate storage containers are placed in the appropriate storage conditions (e.g., temperature, humidity) according to product specifications.
2. 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

1. Complete the Dispensing Log (Annexure-1) with all relevant details, including batch numbers, quantities dispensed, operator names, and any deviations.
2. Ensure that all records are reviewed and signed by the appropriate personnel to verify compliance with the SOP.

5.6 Final Approval

1. The QA team must review all dispensing records and ensure that the batch has been dispensed correctly into intermediate storage.
2. 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

1. Annexure-1: Dispensing Log
2. Annexure-2: Deviation Report Form
3. 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