Standard Operating Procedure for Cleaning and Sanitation

1) Purpose

This SOP outlines the procedures for cleaning and sanitation of pharmaceutical manufacturing facilities and equipment to maintain cleanliness, prevent cross-contamination, and ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all areas, equipment, and surfaces within the pharmaceutical manufacturing facility that require cleaning and sanitation.

3) Responsibilities

The Facilities or Engineering department is responsible for managing the cleaning and sanitation activities. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Cleaning and Sanitation Schedule

1. Develop and maintain a cleaning and sanitation schedule for all areas and equipment based on risk assessments and regulatory requirements.
2. Specify cleaning frequencies, methods, and cleaning agents appropriate for each area and equipment type.

4.2 Cleaning Procedures

1. Remove gross contamination and debris from surfaces before initiating cleaning procedures.
2. Follow validated cleaning procedures, including disassembly of equipment where necessary, to ensure thorough cleaning.
3. Use approved cleaning agents and detergents at specified concentrations and contact times.

4.3 Sanitization Procedures

1. Perform sanitization of cleaned surfaces and equipment using approved sanitizing agents.
2. Ensure proper contact time and application method to achieve effective sanitization.

4.4 Cleaning Validation

1. Validate cleaning procedures for critical equipment and areas to demonstrate effectiveness.
2. Use swab or rinse sampling methods to verify residue levels and microbial contamination.

4.5 Environmental Monitoring

1. Conduct environmental monitoring after cleaning and sanitization to verify cleanliness and compliance with specified standards.
2. Document environmental monitoring results and take corrective actions for any deviations.

4.6 Equipment and Facility Maintenance

1. Maintain equipment and facilities in good repair to facilitate effective cleaning and sanitation.
2. Calibrate and maintain cleaning equipment (e.g., washers, autoclaves) according to validated procedures.

4.7 Personnel Training

1. Provide training to personnel involved in cleaning and sanitation on procedures, safety precautions, and use of cleaning agents.
2. Maintain records of training sessions and competency assessments.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Cleaning and Sanitation Schedule, Cleaning Validation Reports, Environmental Monitoring Records, Training Records

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0