SOP Guide for Pharma

Creams: SOP for Preventing Contamination during Material Dispensing – V 2.0

Auditor

Creams: SOP for Preventing Contamination during Material Dispensing – V 2.0

Standard Operating Procedure for Preventing Contamination during Material Dispensing

Department Creams
SOP No. SOP/CRM/010/2025
Supersedes SOP/CRM/010/2022
Page No. Page 1 of 5
Issue Date 15/04/2025
Effective Date 20/04/2025
Review Date 15/04/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the steps necessary to prevent contamination during the material dispensing process in the Creams Department. This ensures that all materials dispensed for cream formulation are handled in a clean and controlled environment, reducing the risk of contamination and maintaining product integrity.

2. Scope

This SOP applies to all material dispensing activities in the Creams Department, including the dispensing of raw materials, excipients, and active pharmaceutical ingredients (APIs). It covers procedures to minimize the risk of cross-contamination, particulate contamination, and microbial contamination during the dispensing process.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that all material dispensing activities are carried out in accordance with this SOP. The QA Manager is ultimately responsible for overseeing contamination prevention efforts and for ensuring compliance with this SOP during all dispensing activities.

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5. Procedure

5.1 Cleaning and Preparation of Dispensing Area

  1. Before starting any dispensing activities, ensure that the dispensing area is clean, free from dust, and adequately sanitized. The area should be wiped down with an appropriate disinfectant and allowed to dry completely before use.
  2. Ensure that all equipment used for dispensing, including scales, containers, and utensils, is thoroughly cleaned and disinfected. Calibrate dispensing equipment as per the standard operating procedure for cleaning and calibration.
  3. Verify that the environmental conditions, such as temperature, humidity, and air quality, meet the required specifications to prevent contamination during dispensing. Ensure that the air filtration system is functioning correctly.

5.2 Personal Hygiene and Protective Equipment

  1. All personnel involved in the dispensing process must follow strict personal hygiene protocols. Personnel should wash their hands thoroughly before starting any dispensing activity and should wear appropriate personal protective equipment (PPE) such as gloves, lab coats, and face masks.
  2. Ensure that gloves are changed frequently during the dispensing process to avoid contamination. Gloves should be removed before touching any surface that does not directly relate to the dispensing process.
  3. Ensure that all personnel wear hair coverings and that any jewelry is removed to avoid direct contact with materials and minimize the risk of contamination.

5.3 Handling of Materials

  1. Ensure that materials are handled using dedicated utensils and tools that are cleaned and sanitized before each use. Do not reuse tools between different materials to prevent cross-contamination.
  2. When transferring materials from their original containers to dispensing containers, ensure that the materials are not exposed to open air for extended periods. Use sealed containers or covered dispensers when possible.
  3. Materials that are not used immediately should be properly labeled and stored back in their designated storage areas, ensuring they are sealed and protected from contamination.
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5.4 Control of Cross-Contamination

  1. Ensure that all raw materials and excipients are clearly labeled and segregated to prevent the risk of mixing or cross-contamination. The labeling should include the material name, batch number, and any specific handling instructions.
  2. Use dedicated equipment and dispensing tools for each material type. Do not use the same equipment for multiple materials unless it has been thoroughly cleaned and sanitized.
  3. In case of a spillage or contamination during dispensing, immediately implement the contamination control protocol. Clean and sanitize the affected area thoroughly before continuing the dispensing process.

5.5 Environmental Controls during Dispensing

  1. The dispensing process should be carried out in a cleanroom or controlled environment to minimize airborne particles and contamination. Air filtration systems should be checked regularly to ensure that the area remains free of contaminants.
  2. Ensure that the dispensing area is equipped with adequate airflow systems, such as HEPA filters, to maintain a clean environment and prevent particulate contamination.
  3. The temperature and humidity levels in the dispensing area should be monitored and recorded regularly to ensure they are within the acceptable limits for material handling.

5.6 Documentation and Record-Keeping

  1. All dispensing activities should be documented in the Material Dispensing Log. This should include the material name, batch number, quantity dispensed, time/date of dispensing, personnel involved, and any deviations or contamination incidents.
  2. In case of contamination incidents, the event should be recorded in the Contamination Report (Annexure-1). This report should include the root cause, corrective actions taken, and preventive measures implemented to avoid future occurrences.
  3. Review all documentation regularly to ensure completeness and accuracy. Any discrepancies should be addressed immediately and documented in the Corrective Action Log.
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5.7 Training and Continuous Improvement

  1. All personnel involved in material dispensing should receive regular training on contamination prevention techniques and the proper handling of materials. Training should be conducted at least annually or when significant changes to procedures occur.
  2. Continuous improvement should be encouraged by reviewing contamination incidents and corrective actions. Lessons learned should be shared with relevant personnel to improve future dispensing practices and minimize contamination risks.

6. Abbreviations

7. Documents

  1. Material Dispensing Log (Annexure-2)
  2. Contamination Report (Annexure-1)
  3. Corrective Action Log (Annexure-3)

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: Contamination Report

Material Name Batch Number Incident Description Corrective Action Reported By Resolution Date
Excipient A 12345 Spillage during transfer Re-cleaned area, disposed of contaminated material John Doe 15/04/2025

Annexure-2: Material Dispensing Log

Material Name Batch Number Quantity Dispensed Dispensed By Time/Date
Excipient A 12345 500g John Doe 15/04/2025

Annexure-3: Corrective Action Log

Deviation Corrective Action Taken Responsible Person Completion Date
Incorrect Dispensing Amount Re-calibrated scales, retrained personnel John Doe 16/04/2025

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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