Main Activities

1. Verification of Installation

When installing equipment in regulated environments, every detail matters. Proper placement, stable construction, and reliable utilities are essential to ensure safe operations and long-term GMP compliance. The approach covers the following key aspects:

• Orientation and Location: Equipment is placed in the designated cleanroom or production area according to classified zone maps and workflow requirements.
• Structural Stability: Installations are anchored, levelled, and, where necessary, equipped with vibration control to ensure safe and reliable operation.
• Utilities and Connections: All required utilities—such as electricity, water, gases, compressed air, and data—are installed and tested for full functionality, with safety, GMP compliance, and backup systems considered where applicable.
• Installation per Drawings and Specifications: Mechanical installation follows approved piping and instrumentation diagrams (P&IDs), layout drawings, and floor plans to guarantee consistency with project design.
• GMP Compliance: Installations are designed to prevent contamination, allow effective cleaning, and ensure unobstructed access to all critical components.

2. Component and Material Verification

Thorough verification of parts and materials is essential to ensure compliance, traceability, and long-term reliability of equipment used in regulated environments. Each step safeguards product integrity and demonstrates adherence to GMP principles:

• Parts Inventory Check: All major and minor components are verified against purchase orders and supplier documentation to confirm completeness, accuracy, and traceability.
• Material Certificates: Certificates are reviewed for all materials in contact with product or critical process media, ensuring compliance with regulatory requirements and maintaining full documentation for audits and inspections.
• Surface Finish Checks: Stainless steel surfaces in aseptic areas are inspected to confirm required roughness values (Ra). Verification is performed through profilometry or validated vendor documentation, ensuring cleanability, aseptic design, and contamination prevention.

3. Instrument Calibration

Accurate measurement and monitoring are vital for maintaining process reliability and regulatory compliance. Calibration ensures that all critical instruments perform within defined tolerances and provide trustworthy data for regulated operations. These activities are carried out in alignment with GMP requirements (e.g., EU GMP Annex 15, ICH Q10) and international standards such as ISO 17025 for calibration laboratories:

• Instrument List Review: All instruments essential to process control, such as temperature sensors, pressure gauges, and flow meters, are identified and documented in line with qualification requirements.
• Calibration Status Verification: Each instrument’s calibration status is confirmed as current, valid, and traceable to recognized standards, ensuring accuracy and comparability.
• Calibration Labels and Certificates: Instruments are labelled with calibration date, due date, and serial number. Certificates are reviewed, approved, and archived in the IQ documentation to demonstrate compliance during audits or inspections.
• Out-of-Tolerance (OOT) Evaluation: Historical calibration data are assessed for out-of-tolerance results or recurring deviations. Corrective actions and impact assessments are documented according to GMP expectations.

4. Environmental and Safety Checks

Verifying environmental conditions and safety systems is essential to ensure both regulatory compliance and the protection of personnel. These checks demonstrate adherence to GMP principles (e.g., EU GMP Annex 1 for cleanrooms) and occupational safety standards (e.g., ISO 45001, OSHA requirements):

• Facility Conditions Verification: Ambient temperature, humidity, particle counts, and differential pressure are measured and recorded in cleanrooms or controlled zones to confirm they remain within defined specifications.
• Safety Feature Testing: Emergency stops, alarms, pressure relief valves, grounding, shielding, and interlock systems are functionally tested to confirm reliable performance in normal and emergency situations.
• Ergonomics and Accessibility: Installations are reviewed to ensure safe operator access, maintainability, and cleanability, reducing the risk of accidents and ensuring compliance with both GMP and workplace safety requirements.

5. Documentation and Labelling

Clear identification and controlled documentation are critical to ensure traceability, safe operation, and long-term GMP compliance. Proper labelling and document control demonstrate readiness for audits and inspections while supporting daily operations:

• Tagging and Identification: Equipment is marked with asset tags, ID plates, and serial numbers, all of which are recorded in the equipment register and qualification documentation for full traceability.
• Labelling Verification: Flow directions, utility lines, warning signs, and cleaning status indicators (e.g., Clean/Dirty) are checked to confirm visibility, accuracy, and compliance with safety and GMP requirements.
• Document Control: All relevant documentation, such as manuals, wiring diagrams, SOPs, and maintenance logs, is verified as complete, current, and version-controlled in accordance with GMP and quality management standards (e.g., ISO 13485, ICH Q10).