Facility/Equipment Qualification & Validation



Facility Qualification & Validation

Pharmaceutical facilities are required to comply with the FDA's current Good Manufacturing Practices (cGMPs) and other regulatory bodies. The validation effort documents that a facility's design meets the intent of the cGMP's.Our key competencies lie in state -of-the-art laboratories, cGMP areas, pilot plants, facility automation and advanced process controls and specialized utility systems e.g. for sterile manufacturing.

Micron validation team are experts at new facilities, performing HVAC, Validation, and validating other systems as part of a facility qualification like DQ/IQ/OQ/PQ /validation utilities/ facility systems.

Services are rendered from conception to commissioning of each project, enabling the owner to arrive at an optimum design and installation for the following engineering services. Consultation, commissioning & TAB for complete HVAC Projects.

  • Validation Master Plan (VMP
  • Qualification protocols like DQ, IQ, OQ, PQ
  • Validation protocol for utility systems, processes, cleaning, analytical method with validation summary report
  • Actual qualification and Validation support for equipment, system and processes
  • Training