Quality by Design and Quality Risk Management

We offer integrated support from our team of Engineers and GMP experts to the pharmaceutical, biologics and device manufacturers to conceptualize quality by design from product and facility planning to commercialization. Our SMEs insight to your overall need for risk and knowledge management throughout the product life-cycle and hand hold your team in mitigating the threat and in establishing fail-proof quality system.

Quality by Design:

.   Facility Conceptualization, basic engineering, detailed engineering and Qualification;

.   Optimization of the Utilities, Equipment, Analytics and Contact Gases;

.   Validation, Calibration and Preventive maintenance;

.   Product and Process Development, scale-up, Documentation and Employee’s practices;

.   Cleaning validation, clean down verification, containment, upstream, downstream, etc.

Quality Risk Management:

.   ICH Q9/ PICs – Risk assessment, Mitigation, Communication, Review of Residual risk;

.   FMEA, Fish Bone, RCA, FTA, HACCAP, HAZOP, 5-Why, Brain storming etc.

.   Product, Process, Cleaning and Method evaluation, qualification and validation;

.   Qualification and Validation; Calibration and preventive maintenance;

.   Engineering and Quality Change Management and from URS to the Product Quality Life cycle.