Standard Operating Procedure for Documentation during Material Dispensing Activities

Department	Creams
SOP No.	SOP/CRM/008/2025
Supersedes	SOP/CRM/008/2022
Page No.	Page 1 of 6
Issue Date	05/04/2025
Effective Date	10/04/2025
Review Date	05/04/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish standardized documentation practices for all material dispensing activities. This ensures that all materials dispensed during the formulation of creams are accurately documented, traceable, and compliant with GMP standards.

2. Scope

This SOP applies to all material dispensing activities, including the dispensing of raw materials, excipients, and active ingredients, within the Creams Department. It covers the documentation processes, record-keeping, and review procedures necessary to ensure compliance with regulatory and GMP requirements.

3. Responsibilities

• Production Personnel: Responsible for documenting all material dispensing activities, including weights, quantities, and batch numbers, and ensuring that all documentation is complete and accurate.
• Quality Control (QC): Responsible for reviewing material dispensing records for completeness and accuracy and ensuring that any discrepancies are documented and addressed.
• Quality Assurance (QA): Ensures that the documentation process complies with GMP standards, conducts audits to verify documentation practices, and approves material dispensing records for final use in formulation.
• Warehouse Personnel: Responsible for assisting in the documentation of material receipts and transfers to the dispensing area.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that all material dispensing activities are properly documented and comply with this SOP. The QA Manager is ultimately accountable for reviewing all documentation and ensuring compliance with GMP standards.

5. Procedure

5.1 Pre-Dispensing Documentation

1. Before dispensing materials, verify that the material identification logs are up to date and that all required materials are available in the dispensing area. Ensure that each material is appropriately labeled with the correct batch number, and expiry date (if applicable).
2. Review the formulation recipe to confirm the quantities and specifications for each material to be dispensed. Ensure that all required materials are listed in the batch records.
3. Ensure that the dispensing equipment, including scales, containers, and utensils, are properly labeled and documented in the Equipment Maintenance Log, confirming that they have been calibrated and cleaned prior to use.

5.2 Documentation During Dispensing

1. For each material dispensed, record the following information in the Material Dispensing Log:
   • Material name
   • Batch number
   • Quantity dispensed (in weight/volume)
   • Date and time of dispensing
   • Name of the person dispensing the material
2. Any discrepancies, such as excess or insufficient amounts dispensed, must be documented in the Material Dispensing Log. The reason for the discrepancy and any corrective actions taken should also be recorded.
3. Ensure that all documentation is legible, accurate, and signed by the personnel involved in the dispensing process.

5.3 Post-Dispensing Documentation

1. After dispensing, record the final quantity of each material used in the batch, and update the inventory logs to reflect the materials consumed. Any remaining unused material should be returned to its designated storage area, and the quantity should be updated in the inventory system.
2. Once the material has been dispensed, a final review of the Material Dispensing Log should be performed by the QC team to ensure all entries are correct and complete. Any missing or inaccurate documentation must be corrected immediately.
3. Ensure that all records are signed off by the personnel involved in dispensing and verifying the materials. The final approval for the dispensed materials to be used in production must be documented in the Batch Production Record.

5.4 Review and Approval of Documentation

1. The QA team will review all material dispensing records for compliance with GMP requirements. This includes verifying that the correct materials were dispensed in the correct quantities and that all required documentation is complete.
2. The review process should include checks for the following:
   • Accuracy of material details (name, batch number, quantity)
   • Legibility of the documentation
   • Proper signatures and dates
   • Any discrepancies or deviations from the procedure
3. Any discrepancies or missing documentation should be addressed immediately by the QA team. Corrective actions, including retraining or corrective work, should be documented and implemented.

5.5 Archiving and Record Retention

1. All dispensing documentation must be archived in a secure, accessible location. Records should be stored according to the retention policy, typically for a period of at least five years, or as required by regulatory bodies.
2. Paper records should be stored in a controlled environment, and electronic records should be backed up and protected against unauthorized access or loss.
3. The QA team is responsible for ensuring that records are properly archived and maintained, and that they are accessible for audits or inspections as required.

5.6 Corrective Actions for Documentation Issues

1. In the event of incomplete or incorrect documentation, the issue must be investigated immediately. The root cause of the issue should be identified, and corrective actions should be implemented to prevent recurrence.
2. The corrective actions should be documented in the Corrective Action Log, and the impacted documentation should be revised as necessary to ensure accuracy.
3. If the documentation error impacts the production process, the batch should be put on hold, and a review of the batch should be conducted to ensure that the material was dispensed correctly.

5.7 Final Review and Approval

1. After the documentation review process is complete, the final approval for material dispensing records must be obtained from the QA Manager or designee before proceeding with the next steps in the production process.
2. Once approved, the documentation will be filed and stored, and the batch will be released for further processing in accordance with the formulation recipe.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• PO: Purchase Order
• ERP: Enterprise Resource Planning

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Batch Production Record (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 Dispensing

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 Dispensing Log

Material Name	Batch Number	Quantity Dispensed	Dispensed By	Time/Date	Verified By
Excipient A	12345	500g	John Doe	05/04/2025	Jane Smith

Annexure-2: Batch Production Record

Batch Number	Material Name	Quantity Used	Time/Date	Approved By
Batch 12345	Excipient A	500g	05/04/2025	QA Head

Annexure-3: Corrective Action Log

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Incorrect Material Weight	Re-weighed material and re-dispensed	John Doe	05/04/2025

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