Products and Services

cGMP Validation, L.L.C. is one of the largest full service validation firms in the USA offering services for the finished pharmaceutical, bulk pharmaceutical, biotechnology, medical device, and medical diagnostic industries. cGMP Validation has performed validation services for more than 100 companies over the last 5 years.

cGMP Validation has document generation and field execution capabilities including ownership of test equipment required for field execution, as well as in-house procedures necessary to support field execution. The company is staffed with professionals of considerable experience within the pharmaceutical industries and educational disciplines including chemistry, microbiology, engineering, and pharmacy. Most members of the cGMP Validation team have previous experience with operating companies. This provides a unique ability to coordinate with client personnel to assure that all facets of the project start-up and validation are considered. Because projects are locally managed and supported by onsite project managers, we are able to tailor services to meet the unique validation and compliance needs of each individual customer.

Validation Experience

Utilities include:

• HVAC Systems and Associated Controllers
  
• Compressed Air Systems
  
• Electrical Systems
  
• Plant and Pure Steam Systems
  
• Waste Systems

  Water Systems including:

• USP Purified Water Systems
  
• Pretreatment Systems
  
• RO/DI Systems
  
• WFI Systems
  
• Chilled Water and Glycol Systems

  Medical Gas Systems including:

• Carbon Dioxide
  
• Nitrogen
  
• Oxygen

Equipment Validation:

• Autoclaves
  
• Blenders
  
• Cappers
  
• Centrifuges
  
• Depyrogenation Tunnels
  
• Fermenters
  
• Fillers
  
• Filtration Units
  
• Fume Hoods
  
• Glassware Washers
  
• Glove Boxes
  
• Granulators
  
• Inactivation Skids
  
• Laboratory Equipment including HPLCs, GCs, etc.
  
• Lyophilizers
  
• Mixers
  
• Ointments
  
• Ovens
  
• Packaging Equipment
  
• Pumps
  
• Reactors/Biological Reactors
  
• Storage Chambers
  
• Suspensions
  
• Tablet Presses
  
• Tanks
  
• Tunnels
  
• Ultrafiltration Skids

Process Validation:

• Aseptic processing validation
  
• Cleaning validation
  
• Environmental Baselines
  
• Liquids (sterile/non-sterile)
  
• Ointments
  
• Product validation
  
• Suspensions
  
• Tablets

Computer Systems Validation:

• Automation Validation General
  
• BMS
  
• DCS
  
• LIMS
  
• PLCs
  
• SCADA

Note: The above list is representative and not all-inclusive.

CGMP Validation, L.L.C., 5800 Foxridge Drive, Ste. 402, Shawnee Mission, KS 66202. Tel: 913-384-2221; Fax: 913-384-2252.

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