Standard Operating Procedure for Cleaning and Sanitization of Manufacturing Area

1) Purpose

The purpose of this SOP is to establish the procedures for cleaning and sanitizing the manufacturing area to prevent contamination and maintain a controlled environment for the production of injection products.

2) Scope

This SOP applies to all personnel involved in the cleaning and sanitization of the manufacturing area at [Company Name] used for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Performing routine cleaning and sanitization of the manufacturing area.
– Quality Assurance (QA) Department: Monitoring and verifying the effectiveness of cleaning and sanitization processes.

4) Procedure

4.1 Cleaning Procedures
4.1.1 Clean all surfaces, equipment, and floors in the manufacturing area using approved cleaning agents and methods.
4.1.2 Ensure that all cleaning equipment is clean and in good condition before use.
4.1.3 Remove any visible debris or residues from surfaces before applying cleaning agents.
4.2 Sanitization Procedures
4.2.1 Sanitize all cleaned surfaces and equipment using approved sanitizing agents.
4.2.2 Ensure proper contact time for sanitizing agents as specified in the sanitization protocol.
4.2.3 Rinse surfaces with sterile water if required to remove any residues of sanitizing agents.
4.3 Cleaning and Sanitization Schedule
4.3.1 Establish a routine cleaning and sanitization schedule based on the risk assessment and production activities.
4.3.2 Perform cleaning and sanitization after each production batch and at regular intervals during non-production periods.
4.4 Monitoring and Verification
4.4.1 The QA Department should conduct regular inspections and microbiological tests to verify the effectiveness of cleaning and sanitization.
4.4.2 Record all inspection and test results and take corrective actions if any deviations are found.
4.5 Documentation
4.5.1 Maintain records of all cleaning and sanitization activities, including the date, time, personnel involved, and agents used.
4.5.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Cleaning and Sanitization Logs
– Inspection and Test Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0