IQ OQ PQ Medical Devices

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications and quality characteristics. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production.

It is vital to understand the process in detail, investigate the applicable standards and guidelines to determine the process requirements. Process Validation includes various steps –

  • Process Validation Master Plan (PVMP)
  • Process Characterization
  • Equipment Installation and Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Test Method Development (TMD) & Validation (TMV)

Other aspects such as maintenance, verification and process improvement must be continuously monitored and on-going assurance must be conducted to ensure that routine production process remains in a state of control.

IZiel Approach:

IZiel’s approach has been very comprehensive and methodical as depicted in the following flowchart.

process-validation

Why IZiel:

Following factors are considered during the completion of process validation projects –

  • Methodical approach
  • Execute validation project with an onshore-offshore team with a ratio of 1:3
  • Process Validation Master Plan (PVMP)
  • Process Validation Activities
  • Equipment IQ
  • Manufacturing Procedures (WI)
  • Pre-PCS (existing part data analysis)
  • Process Characterization Studies
  • Test Method Validations
  • Operational Qualification
  • Performance Qualification