Creams: SOP for Dispensing High-Sensitivity Materials in Creams – V 2.0

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Creams: SOP for Dispensing High-Sensitivity Materials in Creams – V 2.0

Standard Operating Procedure for Dispensing High-Sensitivity Materials in Creams

Department Creams
SOP No. SOP/CRM/011/2025
Supersedes SOP/CRM/011/2022
Page No. Page 1 of 6
Issue Date 20/04/2025
Effective Date 25/04/2025
Review Date 20/04/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for dispensing high-sensitivity materials used in the formulation of creams. These materials require extra precautionary measures to ensure that their integrity and quality are maintained throughout the dispensing process, minimizing the risk of contamination, degradation, or improper use.

2. Scope

This SOP applies to all high-sensitivity materials, including but not limited to sensitive active ingredients, antioxidants, and other materials that require special handling. The SOP covers the procedures to be followed for dispensing these materials in the Creams Department.

3. Responsibilities

  • Production Personnel: Responsible for dispensing high-sensitivity materials according to the guidelines outlined in this SOP, ensuring that all precautions are followed during the dispensing process.
  • Quality Control (QC): Ensures that all high-sensitivity materials are dispensed correctly, and verifies that all environmental conditions are controlled to prevent degradation or contamination.
  • Quality Assurance (QA): Ensures that the SOP is followed, verifies compliance with GMP standards, and reviews records for completeness and accuracy.
  • Maintenance Team: Ensures that the equipment used for dispensing high-sensitivity materials is regularly calibrated and maintained to prevent any risks associated with improper handling.

4. Accountability

The Head of Creams Manufacturing is accountable for ensuring that the SOP is followed during the dispensing process. The QA Manager is ultimately responsible for overseeing the compliance of the process and ensuring that any deviations are investigated and corrected.

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5. Procedure

5.1 Pre-Dispensing Preparation

  1. Verify the material list for high-sensitivity materials as specified in the formulation recipe. Ensure that all materials are properly identified and available for use.
  2. Ensure that all dispensing equipment, including scales, containers, and utensils, are clean, properly calibrated, and free from contaminants.
  3. Review the Material Safety Data Sheets (MSDS) and handling requirements for the high-sensitivity materials to ensure that the necessary precautions are taken.
  4. Ensure that the environment in which the dispensing will take place meets the required conditions, including temperature, humidity, and cleanliness.

5.2 Handling of High-Sensitivity Materials

  1. High-sensitivity materials must be dispensed in a clean and controlled environment. Any open containers should be sealed immediately after dispensing to prevent exposure to air, light, or moisture.
  2. Use dedicated utensils and dispensing tools for high-sensitivity materials. These tools should not be shared with other materials to prevent cross-contamination.
  3. Handle materials with care to avoid any physical stress or contamination. For example, do not expose light-sensitive materials to direct light for extended periods.
  4. If high-sensitivity materials are sensitive to temperature or humidity, ensure that they are stored and dispensed in a controlled environment that matches their required conditions.

5.3 Monitoring and Verification during Dispensing

  1. The dispensing process must be monitored continuously by the designated personnel to ensure that the correct quantities of high-sensitivity materials are dispensed.
  2. All dispensed materials must be weighed or measured precisely. Discrepancies in weight or quantity should be documented, and corrective actions should be taken immediately.
  3. The QC team should verify the materials dispensed by reviewing the Material Dispensing Log, ensuring that the quantities match the batch requirements.
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5.4 Post-Dispensing Handling

  1. After dispensing, ensure that all materials are transferred immediately to their appropriate storage or production areas, following the necessary storage requirements (e.g., temperature-sensitive materials should be placed in refrigerated storage).
  2. All unused high-sensitivity materials should be properly stored back in their original containers, ensuring that they are sealed and labeled with the batch number, date, and any other necessary details.
  3. Any discrepancies in the quantity of high-sensitivity materials dispensed should be documented in the Material Reconciliation Log and reported to the QA team for investigation.

5.5 Documentation and Record-Keeping

  1. Record all dispensing activities in the Material Dispensing Log, including the following:

    • Material name
    • Batch number
    • Quantity dispensed
    • Dispensing time and date
    • Personnel involved in the dispensing process
  2. Any discrepancies or issues should be noted in the Material Reconciliation Log, and corrective actions should be documented.
  3. Ensure that all dispensing records are signed and dated by the personnel involved and reviewed by the QC and QA teams.

5.6 Corrective Actions for Contamination or Deviation

  1. If contamination or deviation occurs during the dispensing process, immediately stop the activity and notify the QA team. Investigate the cause of the issue and take corrective actions as necessary.
  2. The contaminated material should be discarded according to the contamination protocol, and any affected equipment should be thoroughly cleaned and disinfected.
  3. Document all contamination incidents in the Contamination Report, including the cause of the incident, the corrective actions taken, and any preventive measures implemented.

5.7 Final Review and Approval

  1. After the dispensing process is completed, the QA team should conduct a final review of all dispensing records to ensure that all procedures were followed correctly and that all documentation is complete.
  2. Once the review is complete and all discrepancies have been resolved, the batch is approved for further processing in the cream formulation process.
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6. Abbreviations

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

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Material Reconciliation Log (Annexure-2)
  3. Contamination 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 Dispensing and Contamination Prevention

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
High-Sensitivity Material A 12345 200g John Doe 20/04/2025

Annexure-2: Material Reconciliation Log

Material Name Batch Number Quantity Dispensed Quantity Required Discrepancy Corrective Action Taken
High-Sensitivity Material A 12345 200g 200g No None

Annexure-3: Contamination Report

Material Name Batch Number Contamination Description Corrective Action Taken Reported By Resolution Date
High-Sensitivity Material A 12345 Exposure to light Discarded contaminated material, re-dispensed John Doe 20/04/2025

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
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