SOP Guide for Pharma

Creams: SOP for Handling Excipient Dispensing in Cream Formulations – V 2.0

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Creams: SOP for Handling Excipient Dispensing in Cream Formulations – V 2.0

Standard Operating Procedure for Handling Excipient Dispensing in Cream Formulations

Department Creams
SOP No. SOP/CRM/005/2025
Supersedes SOP/CRM/005/2022
Page No. Page 1 of 6
Issue Date 20/03/2025
Effective Date 25/03/2025
Review Date 20/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish standardized methods for the handling and dispensing of excipients in the formulation of creams. This ensures that all excipients are dispensed accurately, safely, and in compliance with regulatory guidelines, maintaining the integrity and quality of the cream product.

2. Scope

This SOP applies to all excipients used in the manufacturing of creams within the Creams Department. It covers the processes of receiving, inspecting, dispensing, and transferring excipients to ensure their correct usage throughout the production process.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the procedures outlined in this SOP are followed correctly. The QA Manager is ultimately accountable for ensuring compliance with the SOP and for overseeing all corrective actions resulting from deviations or discrepancies.

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5. Procedure

5.1 Preparation for Excipient Dispensing

  1. Review the formulation recipe to confirm the excipients required and their respective quantities. Verify that the correct excipients are available and within their shelf life.
  2. Ensure that all dispensing equipment, such as scales, containers, and utensils, are clean, calibrated, and in good working condition. The dispensing area should be prepared to minimize contamination risks.
  3. Warehouse Personnel should confirm that excipients are stored in the correct storage conditions, as per their respective requirements (e.g., temperature, humidity).

5.2 Dispensing of Excipients

  1. Weigh or measure the required excipients according to the formulation recipe. Use calibrated and approved equipment to ensure accurate quantities are dispensed.
  2. Each excipient should be dispensed into clean, labeled containers. Ensure that the containers are clearly marked with the material name, batch number, and any special instructions (e.g., handling precautions, storage requirements).
  3. If any discrepancies are found in the quantity dispensed, the process must be stopped, and the QA team should be notified for further investigation.

5.3 Handling of Excipients

  1. Personnel involved in dispensing excipients should wear appropriate personal protective equipment (PPE), including gloves and lab coats, to minimize contamination risks.
  2. During the dispensing process, ensure that excipients are handled in a manner that prevents cross-contamination. Utensils and containers used for dispensing must not be shared between different excipients.
  3. Any spillage of excipients should be cleaned immediately, following the appropriate procedures, and documented in the Dispensing Log.
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5.4 Verification of Dispensed Excipients

  1. QC personnel must verify the accuracy of the dispensed excipients. This includes comparing the weighed amounts to the formulation recipe and ensuring that the correct excipient is used.
  2. The verification should also include checking the excipient containers for correct labeling and ensuring that the excipients meet the specifications outlined in the recipe.
  3. If any discrepancies are identified during verification, the materials should be placed on hold, and the issue must be addressed with the QA team before proceeding with the formulation.

5.5 Documentation and Record-Keeping

  1. All dispensing activities must be documented in the Dispensing Log, which includes the excipient name, batch number, quantity dispensed, time, date, and the names of personnel involved in the dispensing process.
  2. The Dispensing Log must be signed by the personnel who performed the dispensing and the personnel who verified the dispensed quantities.
  3. The QA team should review the documentation for completeness and ensure that all discrepancies are resolved and documented properly.

5.6 Storage and Transfer of Dispensed Excipients

  1. After dispensing, the excipients should be immediately transferred to the production area or stored in the appropriate storage area if not immediately used.
  2. Ensure that the transfer process is documented, including the transfer time, quantity, and personnel involved. The excipients should be transported in a manner that prevents damage or contamination.
  3. If excipients are not used immediately, they should be stored in their designated areas, with clear labeling and access restrictions to prevent accidental misuse or contamination.
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5.7 Final Review and Approval

  1. The QA team will review the dispensing records to ensure that the process was conducted according to this SOP. Any deviations or discrepancies found during the review should be investigated and addressed.
  2. Once the dispensing and verification process has been completed and reviewed, the excipients will be approved for use in the cream formulation process.

6. Abbreviations

7. Documents

  1. Dispensing Log (Annexure-1)
  2. Excipient Transfer Log (Annexure-2)

8. References

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

Material Name Batch Number Quantity Dispensed Dispensed By Time/Date
Excipient A 12345 500g John Doe 20/03/2025
Excipient B 67890 300g Jane Smith 20/03/2025

Annexure-2: Excipient Transfer Log

Material Name Batch Number Quantity Transferred Transferred By Transfer Time
Excipient A 12345 500g John Doe 20/03/2025
Excipient B 67890 300g Jane Smith 20/03/2025

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
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