Standard Operating Procedure for Cleaning and Sanitation

1) Purpose

The purpose of this SOP is to establish procedures for the cleaning and sanitation of the manufacturing facility and equipment to ensure a hygienic environment and prevent contamination of pharmaceutical products.

2) Scope

This SOP applies to all areas within the manufacturing facility, including production, storage, and quality control areas, as well as all equipment used in the manufacturing process.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Cleaning Personnel:

Responsible for performing cleaning and sanitation tasks according to the established procedures.

3.2 Production Personnel:

Responsible for ensuring that their work areas and equipment are cleaned and sanitized as required.

3.3 Quality Assurance (QA) Manager:

Responsible for overseeing the cleaning and sanitation process and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Cleaning and Sanitation Schedule:

4.1.1 Develop a cleaning and sanitation schedule based on the facility’s needs and regulatory requirements.
4.1.2 Ensure all areas and equipment are cleaned and sanitized at the required frequency.

4.2 Cleaning Procedures:

4.2.1 Use approved cleaning agents and tools for each area and equipment type.
4.2.2 Follow the specific cleaning procedures outlined for each area and equipment.
4.2.3 Remove visible debris and residues before applying cleaning agents.
4.2.4 Rinse equipment and surfaces thoroughly to remove any cleaning agent residues.

4.3 Sanitation Procedures:

4.3.1 Use approved sanitizing agents and tools for each area and equipment type.
4.3.2 Apply sanitizing agents following the manufacturer’s instructions.
4.3.3 Ensure all surfaces are thoroughly covered and allow the sanitizer to contact for the required duration.
4.3.4 Rinse equipment and surfaces if required by the sanitizing agent’s instructions.

4.4 Documentation and Review:

4.4.1 Document all cleaning and sanitation activities in the Cleaning and Sanitation Log.
4.4.2 Review logs regularly to ensure all activities are completed as scheduled.
4.4.3 Investigate and address any missed or incomplete cleaning and sanitation tasks.

4.5 Verification of Cleaning and Sanitation:

4.5.1 Conduct regular inspections to verify the cleanliness and sanitation of areas and equipment.
4.5.2 Perform microbiological testing to confirm the effectiveness of the sanitation process.
4.5.3 Document verification results and take corrective actions if necessary.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Cleaning and Sanitation Log
2. Inspection Records
3. Microbiological Testing Results

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ISO 14644 Cleanrooms and Associated Controlled Environments

8) SOP Version

Version 1.0