before transfer.

Warehouse Personnel: Ensures that materials are ready for transfer and provides any necessary packaging or labeling as per the production requirements.

Quality Assurance (QA): Ensures that the transfer process follows the SOP and is documented properly. Reviews records for compliance with GMP guidelines.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the material transfer process is carried out correctly and in accordance with this SOP. The QA Manager is ultimately responsible for overseeing the transfer process and ensuring that all required documentation is completed accurately.

5. Procedure

5.1 Pre-Transfer Preparation

1. Verify that all materials to be transferred from the dispensing area are accounted for in the Material Dispensing Log and have been checked by the QC team for compliance with the formulation requirements.
2. Ensure that the materials are properly packaged and labeled with the correct material name, batch number, quantity, and any special handling or storage instructions.
3. Confirm that all necessary equipment, such as trolleys or containers, are clean, suitable for material transfer, and ready for use.
4. Review the production schedule to ensure that the transfer aligns with the production timeline and that all materials are required for immediate use.

5.2 Transfer of Materials

1. Materials should be transferred in batches as per the production schedule. The materials should be securely sealed in containers or bags to prevent contamination or spillage during transfer.
2. The transfer should be conducted by trained personnel using appropriate handling techniques to avoid damage to the materials. Only authorized personnel should be involved in the transfer process.
3. Materials should be transferred directly to the production area without any unnecessary delay to minimize exposure to environmental factors that could compromise material integrity.
4. While transferring, ensure that the materials are not exposed to extreme temperatures, moisture, or any conditions that could affect their quality or stability.

5.3 Documentation During Transfer

1. The transfer of materials must be documented in the Material Transfer Log. This log should include:
   • Material name and batch number
   • Quantity transferred
   • Date and time of transfer
   • Personnel involved in the transfer
   • Signature of the personnel responsible for the transfer
2. Any discrepancies, such as missing or damaged materials during the transfer, must be immediately reported and documented in the Material Transfer Discrepancy Report.
3. A copy of the Material Transfer Log should be reviewed and signed by QC and QA personnel to ensure accuracy and compliance with GMP standards.

5.4 Post-Transfer Activities

1. After the transfer is complete, the materials should be stored in the appropriate location within the production area, as per the production requirements. Ensure that the materials are stored under the proper conditions to maintain their quality.
2. The production personnel should immediately begin the use of the transferred materials in the cream formulation process. Any unused materials should be returned to their designated storage areas with proper labeling.
3. Any discrepancies observed during the transfer (e.g., missing materials or incorrect quantities) must be documented and addressed according to the corrective action procedures.

5.5 Cleanliness and Contamination Prevention

1. Ensure that the transfer containers, tools, and trolleys are regularly cleaned and sanitized to prevent cross-contamination of materials. After each transfer, containers should be cleaned and stored properly.
2. If contamination is suspected, stop the transfer immediately and report it to QA. Investigate the cause of contamination and follow the contamination control protocol to prevent further issues.

5.6 Review and Approval of Transfer Records

1. The QA team will review the Material Transfer Log and Discrepancy Report to ensure that all necessary information is complete and accurate. Any discrepancies or issues should be investigated and corrective actions should be documented.
2. Once the transfer is verified, the batch can proceed with the production process as planned. The final approval from QA is required to ensure compliance with the SOP before moving forward.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Material Transfer Log (Annexure-1)
2. Material Transfer Discrepancy Report (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Material Handling and Transfer

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Transfer Log

Material Name	Batch Number	Quantity Transferred	Transferred By	Time/Date	Verified By
Material A	12345	500g	John Doe	25/04/2025	Jane Smith

Annexure-2: Material Transfer Discrepancy Report

Material Name	Batch Number	Discrepancy Description	Corrective Action Taken	Reported By	Resolution Date
Material A	12345	Quantity mismatch	Re-dispatched missing materials	John Doe	25/04/2025

Annexure-3: Corrective Action Log

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Discrepancy in Transfer	Re-trained staff on proper material transfer procedures	John Doe	26/04/2025

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