Standard Operating Procedure for Cleaning Validation in Otic Manufacturing Unit

1) Purpose

To establish procedures for cleaning validation in the manufacturing of Otic (Ear) Dosage Forms to ensure cleanliness, prevent cross-contamination, and comply with regulatory requirements.

2) Scope

This SOP applies to all equipment and facilities used in the manufacturing, packaging, and testing of Otic dosage forms within the manufacturing facility.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing cleaning validation activities.
Validation Team: Responsible for conducting cleaning validation studies.
Production Department: Responsible for executing cleaning procedures and ensuring equipment cleanliness.

4) Procedure

4.1 Cleaning Procedure Standardization
4.1.1 Cleaning Protocol
4.1.1.1 Develop and approve cleaning protocols for each piece of equipment and area.
4.1.1.2 Specify cleaning agents, procedures, and acceptance criteria.

4.1.2 Equipment Preparation
4.1.2.1 Ensure equipment is properly disassembled, and all removable parts are accessible for cleaning.
4.1.2.2 Conduct pre-cleaning inspections to assess initial cleanliness.

4.2 Cleaning Execution
4.2.1 Cleaning Process
4.2.1.1 Perform cleaning according to approved protocols and procedures.
4.2.1.2 Use validated cleaning agents and equipment for effective cleaning.

4.2.2 Inspection and Verification
4.2.2.1 Inspect equipment and surfaces visually post-cleaning for cleanliness.
4.2.2.2 Conduct swab sampling and analysis to verify cleanliness levels.

4.3 Cleaning Validation
4.3.1 Validation Protocol
4.3.1.1 Prepare cleaning validation protocols including acceptance criteria and sampling methods.
4.3.1.2 Obtain approval from QA before initiating validation studies.

4.3.2 Validation Studies
4.3.2.1 Execute cleaning validation studies as per approved protocols.
4.3.2.2 Perform worst-case scenario testing and evaluate recovery rates.

4.4 Documentation and Reporting
4.4.1 Documentation
4.4.1.1 Document all cleaning validation activities, including protocols, results, and deviations.
4.4.1.2 Maintain records in compliance with GMP requirements.

4.4.2 Reporting
4.4.2.1 Prepare cleaning validation reports summarizing findings and conclusions.
4.4.2.2 Submit reports to QA for review and approval.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices

6) Documents, if any

Cleaning validation protocols
Cleaning records and logs
Swab sampling procedures

7) Reference, if any

GMP guidelines for cleaning validation in pharmaceutical manufacturing

8) SOP Version

Version 1.0