Aide-Memoire for Inspection of Utilities in Pharmaceutical Manufacturing
Introduction
- Technological and Technical Progress: Significant advancements in pharmaceutical manufacturing have been driven by technological and technical progress, particularly in production equipment, technology, quality control, and auxiliary systems like HVAC and media systems.
- PIC/S Attention: PIC/S has recognized the importance of these auxiliary systems and conducted a seminar in 2001 focusing on their inspection.
Purpose
- Document Purpose: This document aims to guide GMP inspectors for training and preparation for utility inspections.
- Aide-Memoire Origin: The Aide-Memoire resulted from the 2001 PIC/S Seminar, designed to facilitate the effective planning and conduct of GMP inspections of utilities.
Scope
- Utility Areas: The Aide-Memoire covers different areas for GMP inspection of HVAC systems, pharmaceutical water, steam, and medicinal gases.
- Non-Exhaustive List: It is not intended to be exhaustive but serves as a guideline for inspections.
Key Sections and Supporting Documents
-
HVAC Systems
- Key Design Parameters: Includes requirements for separate systems, filtration levels, air changes, pressure differentials, and more.
- Qualification: Focuses on DQ, IQ, OQ, and PQ, along with integrity and tightness of filters, number of particles, and recovery tests.
- Walk Round Tour: Inspectors should verify design specifications, filters, air returns, pressure differences, and logbooks.
- Monitoring: Environmental monitoring, chemical residue testing, and alarm system challenges.
- Maintenance and Calibration: Programs, SOPs, records, and breakdown procedures.
- Documentation: Technical data, SOPs, records, validation protocols, and as-built drawings.
-
Pharmaceutical Water System
- Key Design Parameters: Ensures weld quality, passivation of pipeworks, and proper construction materials.
- Qualification: DQ, IQ, OQ, and PQ, including drawings and qualification reports.
- Walk Round Inspection: Verify water quality, feed water, pre-treatment, distillation, storage, distribution, and control systems.
- Documentation: Operational and cleaning parameters, signatures, and user points.
Required GMP Documentation
- Technical Data and SOPs: Detailed documentation for maintenance, calibration, validation, monitoring, deviations, and change control.
- Validation Protocols and Reports: Validations for water quality and system components.
- As-Built Drawings: Complete engineering drawings for reference.
Summary
This Aide-Memoire provides comprehensive guidance for GMP inspectors conducting inspections of HVAC systems and pharmaceutical water systems in pharmaceutical manufacturing. It focuses on key design parameters, qualification processes, walk-round inspections, monitoring, maintenance, and documentation requirements. The document emphasizes the need for thorough verification and documentation to ensure compliance with Good Manufacturing Practices (GMP) standards.
