Pharmaceutical Qualification

Our pharmaceutical facility management consultants are experienced in facility, utility and process equipment commissioning and qualification activities for a variety of pharmaceutical products (i.e., APIs, Solid Dosage forms and sterile Injectables etc.) which help to ensure the safe and efficient start-up of new facilities and changes to existing facilities.

Our team supports each client's engineering and quality functions by preparing commissioning and validation documents, such as, validation master plan, Qualification documents (DQ/IQ/OQ/PQ), System level impact assessments, Data Integrity/ERES assessment as needed for meeting today’s engineering best practices. The documents prepared include:

• Facility Qualification.
• HVAC Qualification.
• Equipment Qualification.
• Utility Qualification (WFI, RO/DI/Purified Water, Pure/Clean Steam, Clean Compressed Air, Nitrogen, etc.).
• Personnel Qualification for Aseptic area operations.