Cleaning Validation Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for cleaning validation in metered-dose inhaler (MDI) production to ensure equipment cleanliness and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in cleaning validation activities within the MDI production facility, including cleaning validation specialists, production supervisors, and quality assurance personnel.

3) Responsibilities

The responsibilities for this SOP include developing cleaning validation protocols, conducting cleaning validation studies, documenting results, and ensuring equipment cleanliness before product manufacturing. Specific roles include:
Cleaning Validation Specialists: Develop and execute cleaning validation protocols and studies.
Production Supervisors: Schedule equipment cleaning and validate cleanliness before use.
Quality Assurance Personnel: Review cleaning validation data and approve equipment for use in production.

4) Procedure

4.1 Protocol Development
4.1.1 Define acceptance criteria for cleanliness based on product and regulatory requirements.
4.1.2 Develop cleaning validation protocols outlining procedures, sampling locations, and analytical methods.
4.2 Cleaning Validation Study
4.2.1 Perform pre-cleaning inspections and swab sampling of equipment surfaces.
4.2.2 Analyze swab samples for residual levels of cleaning agents and active ingredients.
4.3 Documentation of Results
4.3.1 Document cleaning validation study results, including analytical data and compliance with acceptance criteria.
4.3.2 Prepare cleaning validation reports summarizing findings and conclusions.
4.4 Approval and Equipment Release
4.4.1 Review cleaning validation reports with quality assurance and production teams.
4.4.2 Obtain approvals for equipment cleanliness and release for product manufacturing.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Cleaning validation protocols, study reports, swab sampling records, and equipment cleaning schedules should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for cleaning validation requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0