Guidelines for Cleaning Validation in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for cleaning validation to ensure that all equipment used in the manufacturing of vaginal dosage forms is adequately cleaned and free from contaminants.

2) Scope

This SOP applies to all equipment, utensils, and surfaces that come into direct contact with vaginal dosage forms during manufacturing, packaging, and storage within the pharmaceutical facility.

3) Responsibilities

It is the responsibility of the Quality Assurance, Production, and Cleaning departments to implement and follow this SOP to ensure compliance with cleaning validation requirements.

4) Procedure

4.1 Cleaning Validation Plan

1. Develop a cleaning validation plan that outlines the approach, responsibilities, and acceptance criteria for cleaning validation.
2. Identify equipment and surfaces that require cleaning validation based on risk assessment.

4.2 Selection of Worst-Case Scenarios

1. Select worst-case scenarios for cleaning validation based on the most difficult-to-clean product, highest potency, or most toxic substances used.
2. Document the rationale for selecting worst-case scenarios in the validation plan.

4.3 Cleaning Procedures

1. Develop and document detailed cleaning procedures for each piece of equipment and surface.
2. Ensure cleaning procedures include steps for pre-cleaning, cleaning, rinsing, and drying.
3. Use validated cleaning agents and methods to remove residues effectively.

4.4 Sampling and Analytical Methods

1. Define sampling methods (e.g., swab, rinse) and locations for collecting samples from equipment and surfaces.
2. Validate analytical methods used to detect residues of active ingredients, cleaning agents, and microbial contaminants.

4.5 Acceptance Criteria

1. Establish acceptance criteria for residues based on toxicological evaluation, product contact surface area, and dosage form requirements.
2. Ensure acceptance criteria are documented in the cleaning validation protocol.

4.6 Validation Protocol Execution

1. Execute the cleaning validation protocol by performing cleaning procedures on the identified equipment and surfaces.
2. Collect and analyze samples according to the defined methods and acceptance criteria.

4.7 Revalidation

1. Perform revalidation periodically or when there are significant changes to the cleaning procedure, equipment, or product formulation.
2. Document and review revalidation activities to ensure ongoing compliance.

5) Abbreviations, if any

N/A

6) Documents, if any

Cleaning validation plan, cleaning procedures, validation protocols, analytical method validation records

7) Reference, if any

FDA Guidance for Industry: Cleaning Validation, EU GMP Annex 15: Qualification and Validation, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0