and GMP standards.

Warehouse Personnel: Ensures preservatives are stored correctly and available for dispensing as per the production schedule.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that preservatives are dispensed correctly as per this SOP. The QA Manager is accountable for overseeing compliance with the SOP, reviewing any discrepancies, and approving corrective actions.

5. Procedure

5.1 Pre-Dispensing Preparation

1. Verify that the correct preservatives required for the batch are available in the dispensing area and have not passed their expiry date.
2. Review the batch record and formulation recipe to confirm the exact type and quantity of preservative needed.
3. Ensure that all dispensing equipment, including scales, containers, and utensils, are clean, calibrated, and free of any contaminants.
4. If the preservatives are stored in large bulk containers, verify that they are properly sealed and undamaged before opening.

5.2 Weighing and Dispensing of Preservatives

1. Weigh the prescribed quantity of preservative using a calibrated scale. Make sure that the scale is set to zero before use to ensure accurate measurements.
2. Handle preservatives with care to prevent exposure to moisture or contamination. Use clean, dedicated tools and containers to avoid cross-contamination with other materials.
3. For liquid preservatives, measure the required volume using a calibrated pipette or graduated cylinder. Ensure that the liquid is dispensed directly into the appropriate container to minimize exposure to the environment.
4. After dispensing, record the weight or volume in the Material Dispensing Log, including the material name, batch number, quantity, date and time of dispensing, and the personnel involved in the process.
5. If the required amount of preservative is not available or if there is a deviation in the dispensing process, report the issue to the QA team immediately for investigation.

5.3 Handling and Storing Preservatives After Dispensing

1. Immediately after dispensing, seal the preservative container and label it with the batch number, type of preservative, quantity used, and the date it was dispensed.
2. If any excess preservative is available, return it to the designated storage area in accordance with the storage guidelines for preservatives. Ensure that the container is properly labeled and securely sealed.
3. Store the preservatives according to their required storage conditions, such as temperature and humidity control, to maintain their effectiveness and quality.

5.4 Documentation of Dispensing Process

1. Record all dispensing activities in the Material Dispensing Log. The log should include:
   • Material name
   • Batch number
   • Quantity dispensed
   • Dispensing date and time
   • Personnel involved
2. If there are any deviations during the dispensing process (e.g., incorrect quantity, expired preservative), document them in the Material Discrepancy Report and notify the QA team for review.
3. The dispensing log and any discrepancy reports should be signed off by both the dispensing personnel and the QC team to ensure accountability and traceability.

5.5 Corrective Actions for Discrepancies

1. If preservatives are found to be expired or damaged during the dispensing process, immediately stop the process and report it to the QA team. The affected material should be segregated and either discarded or returned to storage as per the company’s material handling procedures.
2. Investigate the cause of any discrepancies or issues encountered during dispensing. The investigation should include reviewing the material storage conditions, handling procedures, and personnel practices.
3. After the investigation, document the corrective actions taken in the Corrective Action Report, and ensure that preventive measures are implemented to avoid similar issues in the future.

5.6 Final Review and Approval

1. The QA team will review the Material Dispensing Log, discrepancy reports, and corrective actions to ensure compliance with GMP and company standards.
2. After the review, the batch can proceed with further processing in the production area, provided all dispensing requirements have been met and no issues were encountered.

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
Preservative A	12345	50g	John Doe	10/05/2025

Annexure-2: Material Discrepancy Report

Material Name	Batch Number	Discrepancy Description	Corrective Action Taken	Reported By	Resolution Date
Preservative A	12345	Expired material used	Discarded and retrained staff	John Doe	11/05/2025

Annexure-3: Corrective Action Report

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Expired Preservative	Re-reviewed inventory, retrained staff	John Doe	12/05/2025

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