Guidelines for Equipment Qualification in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for the qualification of equipment used in the manufacturing of vaginal dosage forms to ensure their proper functioning and compliance with regulatory standards.
2) Scope
This SOP applies to all equipment used in the production, testing, and packaging of vaginal dosage forms within the pharmaceutical manufacturing facility.
3) Responsibilities
It is the responsibility of the Quality Assurance and Engineering departments to ensure that equipment qualification activities are performed according to this SOP.
4) Procedure
4.1 Equipment Qualification Plan
- Develop an equipment qualification plan outlining the scope, objectives, and methods for qualification.
- Identify critical equipment requiring qualification based on risk assessment.
4.2 Installation Qualification (IQ)
- Verify that the equipment is installed correctly and according to manufacturer specifications.
- Check and record equipment dimensions, utilities connections, and environmental conditions.
4.3 Operational Qualification (OQ)
- Ensure that the equipment operates according to predefined specifications.
- Perform functional testing and document results to demonstrate equipment performance.
4.4 Performance Qualification (PQ)
- Validate the equipment’s ability to consistently produce quality products under routine operating conditions.
- Conduct testing using actual production materials and verify output against acceptance criteria.
5) Abbreviations, if any
N/A
6) Documents, if any
Equipment qualification plan, IQ/OQ/PQ protocols, Test reports
7) Reference, if any
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, FDA Guidance for Industry: Process Validation: General Principles and Practices
8) SOP Version
Version 1.0