Standard Operating Procedure for Dispensing Colorants and Fragrances for Creams

Department	Creams
SOP No.	SOP/CRM/016/2025
Supersedes	SOP/CRM/016/2022
Page No.	Page 1 of 5
Issue Date	15/05/2025
Effective Date	20/05/2025
Review Date	15/05/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to ensure the accurate and safe dispensing of colorants and fragrances used in the formulation of creams. These materials, which can be sensitive to contamination or degradation, must be handled with care to ensure consistent product quality, safety, and compliance with regulatory requirements.

2. Scope

This SOP applies to all colorants and fragrances used in the formulation of creams within the Creams Department. It covers the procedures for handling, weighing, dispensing, and documentation to ensure that the ingredients are dispensed in the correct quantity and quality.

3. Responsibilities

• Production Personnel: Responsible for accurately dispensing colorants and fragrances as per the formulation requirements, ensuring proper handling and documentation during the dispensing process.
• Quality Control (QC): Ensures that the correct colorants and fragrances are dispensed, verifies the quantities, and checks the quality of materials before use in the formulation process.
• Quality Assurance (QA): Ensures compliance with this SOP, reviews documentation, and takes corrective actions if any discrepancies are noted.
• Warehouse Personnel: Responsible for ensuring that colorants and fragrances are available for dispensing, correctly labeled, and properly stored until required for use.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring the correct dispensing of colorants and fragrances in accordance with this SOP. The QA Manager is ultimately responsible for overseeing compliance and investigating any discrepancies related to the dispensing process.

5. Procedure

5.1 Pre-Dispensing Preparation

1. Verify that the correct colorants and fragrances required for the batch are available and properly stored in the dispensing area. Ensure that the materials are not past their expiry date.
2. Ensure that all dispensing equipment, such as scales, containers, utensils, and pipettes, are clean, properly calibrated, and free of contaminants.
3. Review the batch record and formulation to confirm the type and quantity of colorants and fragrances required for the batch.
4. If using liquid colorants or fragrances, verify the specific gravity and viscosity to ensure accurate measurement.

5.2 Weighing and Dispensing of Colorants and Fragrances

1. Weigh the required quantity of colorant or fragrance using an appropriately calibrated scale or graduated cylinder. Ensure that the scale is zeroed before use to ensure accuracy.
2. For liquid colorants or fragrances, measure the required volume accurately using a calibrated pipette or graduated cylinder.
3. Ensure that all materials are dispensed directly into the appropriate container for further processing in the cream formulation.
4. Once the material is dispensed, record the quantity in the Material Dispensing Log, including the material name, batch number, quantity dispensed, and date and time of dispensing.
5. If any discrepancies occur (e.g., incorrect quantity, damaged material), immediately report the issue to QA and document it in the Material Discrepancy Report.

5.3 Handling and Storing of Dispensed Colorants and Fragrances

1. Immediately after dispensing, ensure that the colorants and fragrances are transferred to the appropriate area for further use in the formulation process.
2. If there is excess material, return it to its original storage location, ensuring that it is sealed, properly labeled, and stored according to its storage requirements (e.g., light or temperature-sensitive materials).
3. Make sure all returned materials are documented in the Material Return Log.

5.4 Documentation During Dispensing

1. Record all dispensing activities in the Material Dispensing Log. The log should include:
   • Material name
   • Batch number
   • Quantity dispensed
   • Dispensing time and date
   • Personnel involved in dispensing
2. Any discrepancies or issues during the dispensing process should be documented in the Material Discrepancy Report and reviewed by the QA team.
3. Ensure that all dispensing records are signed by the dispensing personnel and reviewed by QC and QA personnel for completeness and accuracy.

5.5 Corrective Actions for Dispensing Issues

1. If there are discrepancies (e.g., incorrect quantity or wrong material), immediately stop the dispensing process and report the issue to QA for investigation.
2. The affected batch should be placed on hold until the issue is resolved. The root cause should be investigated, and corrective actions should be implemented to prevent similar issues.
3. A Corrective Action Report should be generated and reviewed by the QA team. All corrective actions taken should be documented and monitored.

5.6 Final Review and Approval

1. The QA team will review the Material Dispensing Log and any related discrepancy reports to ensure that all procedures have been followed and that all documentation is complete.
2. Once all records are verified and any discrepancies are resolved, the batch can proceed to the next stage in the production process.

6. Abbreviations

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

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Material Discrepancy Report (Annexure-2)
3. Corrective Action Report (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
Colorant A	12345	50g	John Doe	15/05/2025

Annexure-2: Material Discrepancy Report

Material Name	Batch Number	Discrepancy Description	Corrective Action Taken	Reported By	Resolution Date
Fragrance A	67890	Incorrect quantity dispensed	Re-weighed and adjusted	John Doe	16/05/2025

Annexure-3: Corrective Action Report

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Incorrect Dispensing	Revised procedures and retrained staff	John Doe	17/05/2025

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