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

Production Personnel: Responsible for following the procedures outlined in this SOP to prevent contamination during material dispensing, including proper handling and cleanliness practices.
Quality Control (QC): Verifies that materials are dispensed according to the SOP, and conducts inspections to ensure the dispensing environment remains free of contaminants.
Quality Assurance (QA): Ensures that all personnel are trained on contamination prevention practices, and that proper documentation and corrective actions are in place for any incidents of contamination.
Maintenance Team: Ensures that all equipment and dispensing areas are maintained in a clean, operational condition and meet cleanliness standards to prevent contamination.

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.

5. Procedure

5.1 Cleaning and Preparation of Dispensing Area

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.
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.
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

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.
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.
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

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.
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.
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.

5.4 Control of Cross-Contamination

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.
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.
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

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.
Ensure that the dispensing area is equipped with adequate airflow systems, such as HEPA filters, to maintain a clean environment and prevent particulate contamination.
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

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.
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.
Review all documentation regularly to ensure completeness and accuracy. Any discrepancies should be addressed immediately and documented in the Corrective Action Log.

5.7 Training and Continuous Improvement

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.
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

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

7. Documents

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