Standard Operating Procedure for Preventing Contamination in Creams Production
1) Purpose
The purpose of this SOP is to establish procedures for preventing contamination during creams production processes to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in creams production, including production operators, technicians, quality control (QC) personnel, and maintenance staff. It covers procedures for contamination control from raw material receipt to finished product packaging.
3) Responsibilities
It is the responsibility of production supervisors, QC personnel, maintenance personnel, and all production staff to adhere to this SOP. Production supervisors ensure implementation of contamination prevention measures, QC personnel monitor contamination controls, maintenance staff maintain equipment, and production staff follow contamination control procedures.
4) Procedure
4.1 Facility Design and Layout
4.1.1 Design production areas with appropriate segregation of operations (e.g., raw material handling, formulation, filling) to prevent cross-contamination.
4.1.2 Ensure adequate space and flow of materials to minimize congestion and contamination risks.
4.1.3 Implement controlled access and airlock systems to prevent unauthorized entry and minimize environmental contamination.
4.2 Cleaning and Sanitization
4.2.1 Develop and implement cleaning and sanitization procedures for all production areas and equipment.
4.2.2 Use approved cleaning agents and disinfectants suitable for creams production equipment and surfaces.
4.2.3 Schedule regular cleaning activities and maintain cleaning records.
4.3 Personal Hygiene and Gowning
4.3.1 Establish gowning procedures including wearing of appropriate attire (e.g., uniforms, gloves, hairnets).
4.3.2 Implement hand hygiene protocols, including handwashing and use of hand sanitizers.
4.3.3 Provide training on personal hygiene practices to all personnel involved in creams production.
4.4 Raw Material Handling
4.4.1 Inspect incoming raw materials for signs of contamination or damage.
4.4.2 Store raw materials in designated areas with appropriate environmental controls to prevent contamination.
4.4.3 Ensure proper labeling and segregation of materials to avoid mix-ups and cross-contamination.
4.5 Equipment and Tool Maintenance
4.5.1 Maintain production equipment and tools in good working condition through regular inspection, cleaning, and maintenance.
4.5.2 Calibrate equipment as per schedule and maintain calibration records.
4.5.3 Implement preventive maintenance schedules and promptly address equipment malfunctions or defects.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Cleaning and Sanitization Procedures
Equipment Maintenance and Calibration Records
Training Records on Gowning and Personal Hygiene
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO (International Organization for Standardization) 14644: Cleanrooms and associated controlled environments
8) SOP Version
Version 1.0