Guidelines for Facility Design and Layout in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish guidelines for the design and layout of facilities used in the manufacturing of vaginal dosage forms to ensure compliance with Good Manufacturing Practices (GMP).
2) Scope
This SOP applies to all aspects of facility design and layout, including construction, renovation, and maintenance, within the premises of the pharmaceutical manufacturing facility for vaginal dosage forms.
3) Responsibilities
It is the responsibility of the Facility Manager, Engineering Department, and Quality Assurance to ensure compliance with this SOP during the design, construction, and maintenance phases.
4) Procedure
4.1 Facility Design Requirements
- Design facilities with adequate space and layout to prevent cross-contamination between different manufacturing areas.
- Ensure proper segregation of processing, packaging, and storage areas as per regulatory requirements.
- Incorporate suitable HVAC systems to maintain controlled environmental conditions.
4.2 Layout Considerations
- Plan layouts to facilitate smooth flow of materials and personnel, minimizing the risk of errors and contamination.
- Design corridors and aisles to allow easy access for cleaning and maintenance activities.
4.3 Compliance with Regulatory Standards
- Ensure compliance with local regulatory requirements and international GMP guidelines for facility design and layout.
- Regularly review and update facility designs to accommodate process changes and new regulatory requirements.
5) Abbreviations, if any
N/A
6) Documents, if any
Facility blueprints, Design specifications, HVAC system validation reports
7) Reference, if any
ICH Q9 Quality Risk Management, WHO Good Manufacturing Practices (GMP) Guidelines, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
8) SOP Version
Version 1.0
