Every process needs documented evidence proving its assurance towards the desired result.

This high degree of assurance is called validation. Validation process is often essential in determining the quality of the output. At Kelith we provide full life cycle process validation, from its inception , process design , control strategy, qualification, product output. Our dedicated teams help clients understand the basis of design and its proportional outcomes.

Pharmaceutical, biotech, and API manufacture are all closely regulated by governments around the world. Manufacturers must give recorded evidence that their facilities, equipment, and techniques comply with regulatory instructions and can continue to do so.

Rely on Experience

The Kelith Group Validation Consulting team can provide the following validation services.

  • Master Plan Development
  • Commissioning
  • Design Qualification
  • Site Acceptance Testing
  • Turn Over Packages
  • S O P
  • Installation / Operational Qualification
  • Performance Qualification
  • Process, cleaning, Sterilization,Fill/Finish Validation
  • Timely Reviews
standards and localized services

Expertise and deep knowledge of biopharmaceutical

and effective validation strategy