The following table is a list of examples of processes which: (1) should be validated, (2) may be
satisfactorily covered by verification, and (3) processes which may be verifiable, but for business
purposes, validation can be chosen.
b Processes which should be validated[/b]
· Sterilization processes
· Clean room ambient conditions
· Aseptic filling processes
· Sterile packaging sealing processes
· Lyophilization process
· Heat treating processes
· Plating processes
· Plastic injection molding processes
b Processes which may be satisfactorily covered by verification[/b]
· Manual cutting processes
· Testing for color, turbidity, total pH for solutions
· Visual inspection of printed circuit boards
· Manufacturing and testing of wiring harnesses
b Processes for which the above model may be useful in determining the need for[/b]
validation
· Certain cleaning processes
· Certain human assembly processes
· Numerical control cutting processes
· Certain filling processes