PHARMACEUTICAL & BIOTECHNOLOGY
THE NETHERLANDS
Janssen Biologics
Type of facility:
- Bulk Biotech: Monoclonal Antibody
- Approx. Total Installed Cost: €150m
Our scope:
- Preparation of qualification plan
- Impact assessments & criticality analysis
- Vendor assessments
- FAT/SAT support
- IQ, OQ, PQ protocol preparation, field execution & summary reports writing
- Cleaning validation
- Cleaning-In-Place/Steam-In-Place (CIP/SIP) validation
- Critical utilities validation, including end quality testing
- Environment validation, including room temperature, humidity, differential pressure, air change rates & particulates
- Preparation of Standard Operating Procedures (SOPs)
Key Systems included:
Bio-Reactors, Buffer Vessels, Purified Water, Water For Injection, Back Utilities, Washers, Chromatography Columns, Purification Skids, Buffer Vessels, Filters, Dryers, Compressed Gases (Oxygen, Carbon Dioxide, Nitrogen), Process Control System, Clean Rooms, Environmental Monitoring Systems, HVAC & Building Management System
MEDICAL DEVICES & DIAGNOSTICS
WALES, UK
Ortho Clinical Diagnostics
Type of facility:
- Medical Diagnostic Kits
- Approx. Total Installed Cost: €80m
Our scope:
- Preparation of qualification plan
- Impact assessments & criticality analysis
- Vendor Audits
- Documentation management & control
- Cost controls/reporting
- FAT/SAT support
- IQ, OQ, PQ protocol preparation & field execution
- Preparation of summary reports
- Environment validation, including room temperature, humidity, differential pressure, air change rates & particulates
- Preparation of Standard Operating Procedures (SOPs)
Key Systems included:
Buffer Vessels, Dispensing Machines, Vision System, Ultrasonic System, Conveyors, Cartoners, Labelling Machines, Clean/Black Utilities, HVAC, Clean Rooms, Compressed Gases, Process Control System & EMS/BMS
REGULATED CONSUMER PRODUCTS
POLAND
Colgate-Palmolive
Type of facility:
- Medicated Toothpaste
- Approx. Total Installed Cost: €100m
Our scope:
- GMP/Design review & impact assessments
- Preparation of Integrated C&Q plan
- Integrated C&Q planning/scheduling
- C&Q cost controls/reporting
- TOP (Turn-Over Package) definition & organisation
- Set-up & management of the Receipt Verification (RV) process
- General Contractor/Vendor interface management
- Commissioning field oversight
- FAT/SAT support
- IQ, OQ, PQ protocol preparation, field execution & summary reports writing
- Local regulatory licence application support
Key Systems included:
Mixing and Buffer Vessels, Tube Forming Units, Filling Lines, Purified Water, Caustic Storage & Distribution systems, Black Utilities, Chilled Water, CIP Systems, Compressed Gases, Printing/Labelling machines, Process Control System, HVAC & Building Management System
ENGLAND, UK
GW Pharmaceuticals
Type of facility:
- Bulk Chemical: Cannabidiol
- Approx. Total Installed Cost: €80m
Our scope:
- GMP Design review
- Impact assessments
- Preparation of commissioning procedure
- Preparation of overall C&Q plan
- Preparation of validation plan
- Integrated C&Q planning/scheduling
- TOP (Turn-Over Package) definition & organisation
- Set-up & management of the Receipt Verification (RV) process
- Equipment vendor auditing
- FAT/SAT support
- IQ, OQ, PQ protocol preparation & field execution
- Preparation of summary reports writing
Key Systems included:
DAPS, Filter Dryers, Decarboxylation/Extraction Units, Solvent Storage Vessels, CIP Skids, Drum Washing Machine, Mobile Vessels, Pumps, Ultrasonic Baths, Process Control Systems, Black Utilities, Clean Utilities, HVAC & Building Management System
GERMANY
Eli Lilly
Type of facility:
- Automated Warehouse & Distribution Centre
- Approx. Total Installed Cost: €70m
Our scope:
- Preparation of overall C&Q Plan
- Impact assessments & criticality analysis
- Construction quality programme development & execution
- C&Q cost controls/reporting
- TOP (Turn-Over Package) definition & organisation
- Set-up & management of the Receipt Verification (RV) process
- General Contractor/Vendor interface management
- Commissioning field oversight
- IOQ protocol preparation, field execution & summary reports writing
- Documentation management & control
- Oversight of control system vendors, including FAT/SAT oversight
- Site safety support
Key Systems included:
Conveyor Systems, Purified Water, Clean Steam, -18°C Chillers, 2-8°C Secondary Storage, Yokogawa Control system, Ambient Warehouse, Chilled Warehouse (2-8°C), HVAC System, Chillers, Environmental Monitoring and Building Management Systems
ENGLAND, UK
Skanska
Type of facility:
- Hospital
- Approx. Total Installed Cost: €300m
Our scope:
- Preparation of commissioning plan
- Preparation of construction quality plan
- TOP (Turn-Over Package) definition & organisation
- Set-up & management of the Receipt Verification (RV) process
- Commissioning Field Oversight
- Protocol preparation & field execution
- FAT/SAT support
- Preparation of summary reports
Key Systems included:
Autoclaves, Clean Rooms, Purified Water, Black Utilities, HVAC System, Chillers, Environmental Monitoring and Building Management Systems
