Standard Operating Procedure for Equipment Cleaning Validation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for validating the cleaning of pharmaceutical equipment to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

2. Scope

This SOP applies to all equipment used in pharmaceutical manufacturing and processing, including but not limited to mixing tanks, vessels, filling machines, and packaging equipment.

3. Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing and managing the equipment cleaning validation process.
• Production Department: Responsible for conducting cleaning procedures and collecting samples.
• Analytical Laboratory: Responsible for analyzing cleaning validation samples and reporting results.

4. Procedure

4.1. Pre-validation Planning

1. Identify the equipment to be validated for cleaning.
2. Develop a cleaning validation plan that includes a list of equipment, acceptance criteria, sampling locations, and analytical methods.
3. Obtain necessary resources, including cleaning agents, sampling equipment, and analytical instruments.

4.2. Pre-cleaning Inspection

1. Before cleaning, visually inspect the equipment for visible residues, contaminants, or debris.
2. If any residues are found, document their location and nature for reference.

4.3. Cleaning Procedure

1. Follow the approved cleaning procedure for each piece of equipment, including the use of specified cleaning agents, detergents, and sanitizers.
2. Record details of the cleaning process, including cleaning start and end times, personnel involved, and any deviations from the procedure.

4.4. Sampling

1. Collect samples from predetermined