Standard Operating Procedure for Cleaning and Sanitization of Equipment and Facilities in Cutaneous Formulation
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the cleaning and sanitization of equipment and facilities used in the formulation of cutaneous products. It aims to ensure that all equipment and facilities are maintained in a clean and sanitary condition to prevent contamination and ensure product quality and safety.
Scope
This SOP applies to all personnel involved in the cleaning and sanitization of equipment and facilities used in the formulation, manufacturing, testing, and packaging of cutaneous formulations.
Responsibilities
- Production Operators: Responsible for performing routine cleaning and sanitization of equipment and facilities as per the established procedures.
- Cleaning Crew: Responsible for executing detailed cleaning and sanitization activities, including disassembly and reassembly of equipment as required.
- Quality Assurance (QA): Responsible for verifying the effectiveness of cleaning and sanitization activities through inspections, swab testing, and documentation review.
- Facility Management: Responsible for providing necessary resources and support to ensure compliance with cleaning and sanitization procedures.
Procedure
- Preparation: Ensure that all equipment and facilities requiring cleaning and sanitization are properly identified and isolated from production areas.
- Dismantling: Disassemble equipment as per manufacturer’s instructions, ensuring proper labeling and segregation of removable parts.
- Cleaning: Use appropriate cleaning agents and detergents
Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
Documents
- Cleaning and sanitization logbook
- Swab testing records
- Training records
- Deviation reports
Reference
Refer to regulatory guidelines from authorities such as FDA, EMA, WHO, and ICH for specific requirements related to cleaning and sanitization of equipment and facilities in pharmaceutical manufacturing.
SOP Version
Version 1.0