VALIDATION

Clearing the Path to Commercial Supply

At Avecia, we understand that consistency and reproducibility are essential components of pharmaceutical manufacture. We have established a site validation program to define the strategies and requirements necessary to achieve and maintain the state of validation required by US and International GMP regulations. This Validation Master Plan has been implemented across our organization and includes the following programs: 

  • Facility and Utilities Validation
  • Equipment Validation
  • Analytical Method Validation
  • Process Validation
  • Cleaning Validation
  • Computer and Automated Systems Validation

Every program that enters our facility benefits from elements of our validation program, and we take a phase appropriate approach to determining higher levels of validation as warranted by the project’s clinical or commercial status. Our validation approach is risk-based, using the current guidelines and standards for validation activities.

Highlights of Avecia’s validation program include our extensive process validation experience- we maintain an industry leading process validation portfolio with four completed process validations, and additional programs currently underway.

Our process validation program is current with the updated practices and principles in the 2011 FDA Process Validation guideline. Our analytical development department oversees phase appropriate method development and validation activities for raw material and product testing. Click here for more information on Avecia’s Analytical Development capabilities and expertise.

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