Standard Operating Procedure for Cleaning Validation

1) Purpose

The purpose of this SOP is to establish procedures for validating the cleaning processes of manufacturing equipment to ensure they consistently remove residues to acceptable levels.

2) Scope

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

3) Responsibilities

The responsibilities of this SOP include:
– Production Operators: Performing cleaning processes according to the validated procedure.
– Quality Control (QC) Department: Conducting tests to verify cleanliness.
– Quality Assurance (QA) Department: Reviewing and approving cleaning validation protocols and reports.

4) Procedure

4.1 Development of Cleaning Validation Protocol
4.1.1 Define the equipment to be cleaned and the specific residues to be removed.
4.1.2 Develop a cleaning validation protocol outlining the procedures, acceptance criteria, and sampling methods.
4.2 Execution of Cleaning Validation
4.2.1 Perform the cleaning process as outlined in the validation protocol.
4.2.2 Collect samples from equipment surfaces at predetermined locations.
4.2.3 Analyze samples for residues using validated analytical methods.
4.3 Evaluation of Cleaning Validation Results
4.3.1 Compare analytical results against predefined acceptance criteria.
4.3.2 Investigate and document any deviations or failures.
4.3.3 Repeat cleaning and validation process if acceptance criteria are not met.
4.4 Documentation of Cleaning Validation
4.4.1 Prepare a cleaning validation report summarizing the protocol, execution, results, and conclusions.
4.4.2 Maintain all records of cleaning validation, including protocols, raw data, and reports.
4.4.3 Ensure all records are signed and dated by the responsible personnel.
4.5 Revalidation of Cleaning Processes
4.5.1 Perform periodic revalidation of cleaning processes to ensure continued effectiveness.
4.5.2 Revalidate cleaning processes whenever there are changes to the equipment, cleaning agents, or production processes.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control

6) Documents, if any

– Cleaning Validation Protocols
– Cleaning Validation Reports
– Analytical Test Results

7) Reference, if any

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

8) SOP Version

Version 1.0