Process Validation is a general concept that may include actual Process Validation (PV), Analytical Methods Validation (AMV), and Cleaning Validation (CLV).
In the course of actual Process Validation (PV) reliability of process technology used for the manufacture of each semi-product/final product at each independent process step is tested, i.e. that the processes (within their specified design parameters) are capable of repeatedly and reliably producing semi-product/finished product of the required quality.
In the course of Analytical Methods Validation (AMV) capability of used analytical methods of carrying out specific tasks reproducibly and reliably is checked. Analytical methods are used for raw materials incoming control, in-process control, quality control of finished products, cleaning quality testing and validating other processes.
In the course of Cleaning Validation (CLV) capability of cleaning processes applied to equipment/rooms are tested for ensuring required cleanliness repeatedly and reliably.
Pharma Group Baltic offers:
Development of PV/CLV concept/program
Assistance/support in development of PV/CLV Protocols by the Clients specialists
Assistance/support in execution of PV/CLV