Risk Based Validation

GMP Engineering utilizes Process Risk Assessment methodology and tools to provide pragmatic, objective, and cost effective process validations in order to effectively achieve substantial FDA compliance.

We employ Project Life Cycle models according to GAMP, Process Module Design principles and we Manage Projects assuring a simplified, orderly and structured validation process.

  • cGMP Audits
  • Hazard Analysis of Critical Control Points (HACCP)
  • Validation Master Plans
  • Factory Acceptance Tests
  • Qualification: Design, Installation, Operation, Performance
  • Standard Operation Procedures (SOPs)

Read about our Experience...

                
Algorithmic Image




   
View Site Map
    Copyright © 2009 by GMP Engineering Ltd. All rights reserved.Web site solution designed & developed by SGJP design 
cGMP, GMP, Engineering, Toronto, Ontario, Process Engineering, Project Management, HACCP Validation, Pharmaceutical, Food Grade Manufacturing. Experts in hygienic and sterile engineering process technology and we strive to deliver outstanding engineering services and products in the form of complete solutions to our clients. At GMP Engineering we built on the needed skills to execute individual project tasks with an in-depth understanding of process technology, a strong project management culture and many years of staff experience. GMP Engineering is a young dynamic company with vision. We strive to deliver outstanding engineering solutions to our clients in the pharmaceutical, biotech, nutraceutical, health care and chemical sectors in Canada and the US. We are experts in hygienic and sterile engineering process technology and we strive to deliver outstanding engineering services and products in the form of complete solutions to our clients. We operate as a value-added extension of your organization and provide those services that lie outside your core competencies in a timely, cost-effective and consistently accurate manner. Know-how Tank farms Raw material handling Compounding Formulation (Blending and Dosing) Fluid handling Separation Sterile filtration Purification (Ultrafiltration and chromatography) Cleaning-in-Place, Steaming-in-Place and Drying-in-place (CIP/SIP/DIP) Sterilizers Washers Bioreactors Solids Handling Bio-processes Pure fluids (Purified Water, Water for Injection and Pure Steam) Customer Base Pharmaceuticals Blood Products Biotechnology Nutraceuticals Cosmetics Food and beverage Expertise Solutions Suspensions Aerosols CreamsandLotions Pastes and Gels Solid Dose