Process Validation

Our expertise in Process Validation is the product of dozens of years of professional work in the Pharmaceutical industry and the Medical Devices industry. Developing these industry specific processes requires meeting the strict standards of the European and the Israeli standardization, as well as the FDA. 


Process Validation 
Our work process begins with writing a Process Validation Master Plan. In this document we summarize all work procedures and processes, protocols, reports, as well as characteristics of critical parameters of every stage in the required production process (solids, semi-solids, powders, liquids and sterile products, packaging processes, etc.)
In addition, we provide to our clients process related consulting services on procurement of production systems and apparatuses.
Subsequently to the completion of the first Three Process performance Qualification (PPQ) batches, we continue to support the routine production process in accordance with the New FDA Validation Guide Requirements, to ensure that GMP principles are maintained. 
A careful attention is devoted to finding a solution for problems that surface during the transitional phase between R&D and Production. 
We remain Partners to the Routing Maintenance Processes, as well as Live Status Updates during change inspections, production line changes, standardization changes, or preparation of report documentation and presentation of the production array during regulatory inspections.