Process Validation: Pharma Vs. Medical Device

 

Process validation is a formal methodology that allows companies to manufacture products on approved and qualified equipment, with a defined process leading to products that consistently meet their predetermined specifications and quality requirements.


Process Validation for medical devices is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.

Pharma Vs. Medical Device Process Validations, Points to be considered as bellow.

  • 1.       Qualification Strategy
  • 2.       Timing of Critical Parameters
  • 3.       Measurement Method
  • 4.       Process
  • 5.       Equipment
  • 6.       Batch Production
  • 7.       Process Validation

Pharmaceuticals and Medical Devices must be manufactured to the highest quality levels. Product testing by itself does not guarantee the quality of the product. Process Validation assists in building the quality into the product and has proven to be an important tool for quality management of Pharmaceuticals and Medical Devices.

IZiel has successfully delivered various projects through the Onshore-Offshore Work Model thereby completing projects faster and with major cost savings. IZiel team works together with the client to plan, execute, compile reports, and receive stakeholder approvals for all process validation projects.



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