Design & Engineering
- Development – Conceptual Engineering Design, User Requirement Specifications (Facility, Equipment & Critical Support Systems), Factory Acceptance Testing, Plans & Processess (Facility/ Equipment Maintenance, Instrument Calibration).
- Reviews and Gap Analysis – Facility Design, Equipment & Critical Support System Design and Specifications, Plans & Processess (Facility/ Equipment Maintenance, Instrument Calibration).
Designing a modern, GMP compliant pharmaceutical facility is a daunting task within an increasingly complex & demanding business environment, and continuously changing/ evolving regulatory landscape. A pharmaceutical facility is constantly challenged to respond to evolving developments in technology and external regulation. Inadequate and/ or inappropriate efforts made during the initial stages of a pharmaceutical facility design could result in commissioning of a facility that will not help in delivering faster, better, and an assured quality/ valued products to the market. Additionally, a wrong/ inadequate design could remain as an irreversible and life-long potential GMP compliance risk thus impacting the manufacturers business continuity.