Equipment Management
Equipment management involves the systematic tracking, maintenance, and optimization of physical assets and equipment throughout their lifecycle. This includes inventory management, preventive maintenance scheduling, repair tracking, and ensuring compliance with safety regulations.
EQUIPMENT MANAGEMENT TASKS
- Purchasing: Buying new equipment
- Maintenance: Scheduling repairs and preventive maintenance
- Inventory: Tracking equipment levels and condition
- Transportation: Moving equipment between locations
- Storage: Keeping equipment in a safe place
- Disposal: Getting rid of old or obsolete equipment
EQUIPMENT PROCUREMENT
1. Requirement Assessment & Planning
- Identify the equipment needs based on manufacturing processes, production volume, and compliance requirements.
- Define user requirements specifications (URS), considering factors like material compatibility, automation level, and regulatory adherence (e.g., FDA, EMA, GMP).
- Conduct feasibility studies and budget planning to align with financial and operational goals.
2. Vendor Selection & Evaluation
- Research potential suppliers with experience in pharmaceutical equipment manufacturing.
- Evaluate vendors based on quality certifications (ISO 9001, GMP compliance, CE marking).
- Conduct audits or factory visits to verify the supplier’s manufacturing and quality control processes.
- Request for Quotation (RFQ) and technical proposals from shortlisted vendors.
3. Technical Review & Compliance Check
- Factory Acceptance Testing (FAT)
- Compare equipment specifications against URS and regulatory guidelines.
- Assess equipment documentation, including validation support, material certificates, and calibration details.
- Ensure the equipment meets cGMP, 21 CFR Part 11 (if software-based), and cleanroom classification requirements.
4. Procurement & Contract Finalization
- Negotiate pricing, delivery timelines, payment terms, and service agreements.
- Establish agreements for after-sales support, spare parts availability, and training.
- Issue a Purchase Order (PO) and ensure all required documentation is in place.
5. Equipment Delivery & Installation
- Coordinate logistics, customs clearance (if imported), and site readiness for installation.
- Site Acceptance Testing (SAT)
- Perform incoming inspection to verify compliance with specifications.
- Supervise installation and ensure alignment with the facility layout and safety standards.
6. Qualification & Validation
- Conduct Installation Qualification (IQ) to verify correct setup and documentation.
- Perform Operational Qualification (OQ) to ensure the equipment functions as intended under test conditions.
- Carry out Performance Qualification (PQ) by running the equipment under actual production conditions.
- Validate software systems if applicable (Computer System Validation – CSV).
7. Training & Handover
- Train operators, maintenance personnel, and quality assurance teams.
- Establish Standard Operating Procedures (SOPs) and maintenance schedules.
- Conduct final acceptance testing before full-scale production.
8. Ongoing Maintenance & Compliance
- Implement preventive maintenance schedules and periodic calibrations.
- Maintain logs for audits and inspections.
- Regularly update equipment documentation and ensure compliance with evolving regulatory standards.
EQUIPMENT MANAGEMENT SOFTWARE
Equipment Management software plays a critical role in streamlining the Equipment Management process. By automating many of the manual tasks involved in deviation management, the software can help companies identify, report, investigate, document, and resolve deviations more quickly and effectively.
LINKS
FDA
- 21 CFR Part 211, Subpart C – Buildings and Facilities
- 21 CFR Part 211, Subpart D – Equipment
- 21 CFR Part 211, Subpart F – Production and Process Controls, 211.105 Equipment identification
- 21 CFR Part 211, Subpart I – Laboratory Controls, 211.160(b)(4)
- 21 CFR Part 211, Subpart J – Records and Reports, 211.182 Equipment cleaning and use log.
- 21 CFR Part 820, Subpart G – Production and Process Controls, 820.70 Production and process controls
- 21 CFR Part 820, Subpart G – Production and Process Controls, 820.72 Inspection, measuring and test equipment.
- 21 CFR Part 820, Subpart G – Production and Process Controls, 820.75 Process validation
- 21 CFR Part 820, Subpart H – Acceptance Activities, 820.80(e)(5) Acceptance Records
- 21 CFR Part 820, Subpart M – Records, 820.181 Device master record
ISPE
- GAMP 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- GAMP Good Practice Guide: Calibration Management
- GAMP Good Practice Guide: GxP Process Control Systems
- Good Practice Guide: Asset Management
- Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems
- Good Practice Guide: Controlled Temperature Chambers
- Good Practice Guide: Critical Utilities GMP Compliance
- Good Practice Guide: Decommissioning Pharmaceutical Equipment and Facilities
- Good Practice Guide: Equipment Reliability
- Good Practice Guide: Heating, Ventilation and Air Conditioning
- Good Practice Guide: HVAC and Process Equipment Air Filters
- Good Practice Guide: Maintenance
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Operation Management
- Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems
- Good Practice Guide: Packaging, Labeling and Warehouse Facilities
- Good Practice Guide: Process Gases
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Sampling Pharmaceutical Water, Steam and Process Gases
- Good Practice Guide: Single Use Technology
- Good Practice Guide: Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems
- Good Practice Guide: Unique ID of Glass Primary Containers
- Baseline Guide: Sterile Product Manufacturing Facilities
- Baseline Guide: Water and Steam Systems
- Baseline Guide: Commissioning and Qualification
- Baseline Guide: Biopharmaceutical Manufacturing Facilities
- Guide: Cleaning Validation Lifecycle – Application, Methods and Controls