Commissioning and Qualification

GST Enterprises executes commissioning of start-up production facilities, process equipment and control systems . Our approach to qualification incorporates our in-depth understanding of global regulatory guidelines (USFDA, EMA, MHRA, Health Canada, WHO). We provide onsite / offsite C&Q services for BioPharma, Vaccines, Oral Solid Dosage, Fill / Finish facilities.

• Cleaning Validation.
• Circuit OQ and PQ Development, Execution, and Final Reports.
• Commissioning Documentation and Support.
• DQ, IQ, OQ and PQ Protocol Development and Execution and Reports.
• Equipment and Qualification.
• Factory Acceptance Testing / Site Acceptance.
• Process Validation.
• Risk-based approaches (ASTM E2500, ICH-Q9 principles).

To Know more please write to us at info@gst-enterprises.com