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E-mail: info@ivyworks.net

Compliance Services

Validation

Validation

What We Offer

The team at IVY Works' has a wide range of exposure to all aspects of validation and qualification. We have worked with clients in North America, Europe and Asia. Our approach to validation is based on the latest industry standards like GAMP 5, ASTM E2500 and ICH guidelines. The consolidated approach is risk based and practical with a focus on satisfying regulatory requirements. Our engagement with clients is flexible based on their requirements; ranging from a single system to an entire process line or the entire plant.

Packaging Equipment Examples:

  • Thermoformer
  • Blister Packing
  • Bottle Filling
  • Labeling
  • Induction Sealing
  • Checkweigher
  • Cartoning

Process Equipment Examples:

  • Reactor
  • Hydrogenator
  • Fluid Bed Drier
  • Granulators
  • Vacuum Driers
  • Tablet Presses
  • Capsule Filling
  • Tablet Coater

Utilities / Facilities Examples

  • Compressed Air
  • HVAC
  • Hot Water System
  • Purified Water System
  • Water For Injection System
  • Downflow / Sampling Booths
  • Gas Systems (Oxygen, Carbon Di Oxide, Nitrogen)

Testing Equipment Examples

  • Moisture Analyzer
  • Hardness Tester
  • Torque Tester
  • Tablet Metal Detector
  • Tablet/Capsule Counter