Procedures for Validation

Dear All,

Is it all IQ, OQ, PQ can only be started with a Validation Plan? is it possible that a simple/single step machine qualification (IQ,OQ,PQ) conducted without a process validation plan? because i am always need to revise the validation plan each time a new duplicate machine is bought. or the validation procedures are like that and i have to follow :frowning:

if the new machine is the same, or similar enough that the qualification is being performed in the same way; try writing a Master qualification protocol in a ‘fill in the blank’ format which will enable you to print off a ‘working copy’ from the master each time you need to qualify a new piece of equipment

i would have to read your ‘validation plan’ to know how you have things set up. it could be that you have a master plan for validation that is too specific. it should be written in a little more general way that states that master protocols will be written for each type of equipment - that will give you more flexibility.