Standard Operating Procedure for Cleaning Validation in Manufacturing Area

1) Purpose

The purpose of this SOP is to define the procedures for cleaning validation in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and surfaces.

2) Scope

This SOP applies to all cleaning validation activities conducted within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Personnel

• Perform cleaning procedures according to validated methods.
• Document cleaning activities accurately.

3.2 Quality Assurance (QA) Personnel

• Review and approve cleaning validation protocols and reports.
• Conduct audits to ensure compliance with cleaning procedures.

4) Procedure

4.1 Cleaning Validation Plan

1. Develop a cleaning validation protocol based on product and equipment specifications.
2. Define acceptance criteria for cleanliness.

4.2 Cleaning Procedure

1. Perform pre-cleaning inspection to remove visible residues.
2. Apply cleaning agents and methods validated for specific equipment.
3. Rinse equipment thoroughly to remove cleaning agents.

4.3 Sampling and Analysis

1. Collect swab or rinse samples from critical equipment surfaces.
2. Analyze samples for residual levels of cleaning agents and contaminants.

4.4 Documentation and Reporting

1. Compile cleaning validation data and results into a final report.
2. Obtain QA approval for cleaning validation documentation.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Cleaning Validation Protocol
• Cleaning Validation Reports
• Swab/Sample Analysis Records

7) Reference, if any

EMA Guideline on Cleaning Validation
FDA Guide to Inspections: Validation of Cleaning Processes

8) SOP