Validation is the documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Its Includes testing methods, cleaning and transportation validation as well as the qualification of IT Systems, utilities and equipment.
Lean Six Sigma is a combination of two popular Process Improvement methods—Lean and Six Sigma—that pave the way for operational excellence. Eliminating waste and variability implies to have a robust and effective processes.
Process optimization consist of adjusting a process to optimize some specified set of parameters. The main goal is to reduce and/or eliminate most of waste and mistakes while achieving the process objective.
GMP is to ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production.
The performance optimization of your manufacturing and business processes can be carried out only by adopting the Good performance Practices (GPP). improving your processes will increase the performance of of overall activities.
Cannabis and Cannabis-Derived Products must be produced in compliance with Good Agricultural & Collection Practices (GACP), Good Production Practices (GPP) and Good Manufacturing Practices (GMP) for process and quality performance
Our consultants are expert in Facility, Utilities, System and equipment, qualification. We use a Risk-Based Approach to Qualification that aligns with the EU, Health Canada, TGA, PMDA and USFDA thinking on qualification.
Being in compliance means you must control ambient conditions in production, laboratory and storage areas to ensure product quality. Mivado GP can provide instruments and resources to support the extensive GMP measures and data collection for cleanroom qualification.
Contamination Control Strategy, a planned set of actions, processes and control, should be implemented across the facility in order to define all critical points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination.