Standard Operating Procedure for Cleaning Between Batch Runs

1) Purpose

The purpose of this SOP is to establish procedures for cleaning equipment and manufacturing areas between batch runs to prevent cross-contamination, ensure product quality, and maintain compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the cleaning and sanitization of equipment and facilities within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Operators

• Execute cleaning procedures according to approved SOPs.
• Verify cleanliness of equipment and work areas.

3.2 Cleaning Validation Team

• Verify effectiveness of cleaning procedures through validation studies.
• Approve cleaning processes and equipment readiness for production.

4) Procedure

4.1 Pre-Cleaning Preparation

1. Review batch records and cleaning instructions.
2. Gather necessary cleaning supplies and equipment.

4.2 Equipment and Area Cleaning

1. Dismantle equipment components as required for cleaning.
2. Apply appropriate cleaning agents and sanitizers.
3. Rinse and dry equipment thoroughly.

4.3 Cleaning Verification

1. Perform visual inspections and swab sampling for residue testing.
2. Collect samples for analytical testing if required.

4.4 Documentation and Reporting

1. Document cleaning activities and results in cleaning records.
2. Report any deviations or issues to supervisors and QA.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Cleaning SOPs and Checklists
• Cleaning Validation Reports
• Swab Sampling Logs

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Cleaning Validation

8) SOP Version

Version 1.0