Packaging of Pharmaceutical Products, The Netherlands, 2020
Project Engineering of Clean Utilities (e.g., PW systems)
• Preparation of essential project documents; URS and ITB (invitation to bid)
Project Engineering and Qualification & Validation Services for Central Lab Systems
• GMP washer (Creation of URS, Validation Plan including preparation of Q&V docs and execution of qualification
• Autoclave (Preparation of Q&V docs including execution)
Quality Services and Validation of Packaging Systems
• Preparation and Execution of Validation Protocols for Vaccine Packaging Systems (including Serialization).
• Setting up Change Requests and Deviations
Vaccine production site, The Netherlands, 2021
Qualification and Validation of Vaccine Production systems,
• Validation of Bioreactors (Validation Package Including Sterile Hold Time and Thermal Mapping Tests)
• Commissioning and Qualification of Central UtilitiesCommissioning & Qualification of Decontamination Systems (Thermal Mapping Tests)