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Experience  /  Selected project profiles

Selected project profiles

Pharmaceutical, Biotechnology & Mission Critical

Germany - A large USA multi-national company

Type of facility / installation:

  • Automated warehouse
  • Total Installed Cost: $50M

Scope:

  • Construction quality, commissioning & qualification management
  • Impact assessments & preparation of ICQ plan
  • ICQ planning / scheduling
  • C&Q cost controls / reporting
  • TOP (Turn-Over Package) definition & organisation
  • Set-up & management of the Receipt Verification (RV) process
  • Preview / preparation of commissioning documentation in German
  • GC / Vendor interface management
  • Commissioning field oversight
  • FAT / SAT support
  • IOQ protocol preparation, field execution & summary reports writing
  • Site safety support

Pharmaceutical, Biotechnology & Vaccines

Belgium - A large USA multi-national company


Project 1


Type of facility / installation:

  • Biotech Facility (Vaccine Manufacturing)
  • Total Installed Cost: $85M

Scope:

  • Commissioning & Qualification support of GMP systems, like Clean Rooms (ISO 6, 7 and 8) and Utilities (Purified Water, Water for Injection, Clean Steam, Pharmaceutical Compressed Air, Nitrogen)
    • Validation Project Plans & Reports
    • Risk / Impact Assessments
    • Vendor assessments
    • FAT / SAT support
    • Verification testing (ASTM E-2500)
    • System Acceptance Release Reports
  • QA Validation oversight
    • Active input on validation approach and agreement on final proposal
    • Quality Authority review and sign-off on all qualification and validation documents

Project 2


Type of facility / installation:

  • Clinical Supply Facility (IND Investigational New Drugs)
  • Total Installed Cost: $45M

Scope:

  • Commissioning & Qualification management of GMP systems, like Parts Washer and Autoclave
    • Vendor assessments
    • FAT / SAT support
    • Verification testing (ASTM E-2500)
    • System Acceptance Release Reports
    • Validation support (cleaning and sterilization cycle development)
  • QA Validation oversight
    • Active input on validation approach and agreement on final proposal
    • Quality Authority review and sign-off on all qualification and validation documents

Project 3


Type of facility / installation:

  • Adjuvant Formulation Suite (supporting Vaccine Manufacturing)
  • Total Installed Cost: $12M

Scope:

  • Commissioning & Qualification support of GMP systems, like Vessels
    • Risk / Impact Assessments
    • Vendor assessments
    • FAT / SAT support
    • Verification testing (ASTM E-2500)
    • System Acceptance Release Reports
  • QA Validation oversight
    • Active input on validation approach and agreement on final proposal
    • Quality Authority review and sign-off on all qualification and validation documents

Sweden - A large USA multi-national company

Type of facility / installation:

  • Biotech facility
  • Total Installed Cost: $200M

Scope:

  • Construction quality management program
  • Commissioning management of GMP & non GMP systems
    • Impact assessments
    • Commissioning planning / scheduling
    • TOP (Turn-Over Package) definition & organisation
    • Plant expediting
    • FAT / SAT support
  • Qualification managed by client

Regulated Consumer Products

Poland - A large USA multi-national company

Type of facility / installation:

  • Dental Cream Facility
  • Total Installed Cost: €100M

Scope:

  • Commissioning & qualification management
  • GMP / Design review & impact assessments
  • Preparation of ICQ plan
  • ICQ planning / scheduling
  • C&Q cost controls / reporting
  • TOP (Turn-Over Package) definition & organisation
  • Set-up & management of the Receipt Verification (RV) process
  • GC / Vendor interface management
  • Commissioning field oversight
  • FAT / SAT support
  • IOQ protocol preparation, field execution & summary reports writing

Building & Mission Critical

UK - A medium sized construction contractor

Type of facility / installation:

  • Biology Development Laboratories
  • Total Installed Cost: £5M

Scope:

  • Develop commissioning plan
  • Set up and management of Receipt Verification (RV) process
  • Set up and management of Installation Verification (IV) process
  • Oversight of field commissioning activities

Chemical

Caribbean - A Caribbean energy & electricity company

Type of facility / installation:

  • Gas pipe-line
  • Total Installed Cost / Investment Value: $200M

Scope:

  • Inspection, expediting, factory acceptance tests and certification of a gas pipe line

Building

UK - A global construction contractor

Type of facility / installation:

  • 8-storey office complex
  • Total installed cost: £70M

Scope:

  • Commissioning Management Services incl
    • Develop commissioning plan
    • Develop overall commissioning schedule
    • Identify critical path for building start up
    • Oversight of field commissioning for building utilities

UK - A global construction contractor

Type of facility / installation:

  • Schools (3 of)
  • Total Installed Cost: £8M

Scope:

  • Commissioning services
    • Develop commissioning plan
    • Oversight of field commissioning for building utilities

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