Validation is the documented act of demonstrating that any procedure, process, or activity will consistently lead to the expected results. It 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 having robust and effective processes.
Process optimization consists of adjusting a process to optimize some specified set of parameters. The main goal is to reduce and/or eliminate most ofthe waste and mistakes while achieving the process objective.
GMP is to ensure 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 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 experts in Facility, Utilities, System, and equipment qualification. We employ a Risk-Based Approach to Qualification that aligns with the thinking of the EU, Health Canada, TGA, PMDA, and USFDA on qualification.
Complying 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 controls, 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.
Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. Eliminating or minimizing factors that cause inaccurate measurements is a fundamental aspect of instrumentation design.
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