I’m very new to validation and this site and I can’t seem to find any information on this topic. When I talk to coworkers about this matter give me different answers on this topic. My question is when you move a piece of packaging and/or manufacturing equipment do you have to do the IQ/OQ/PQ over again, the IQ/OQ, or only the PQ?
Also, if anyone can give me good resources on validations that would be greatly appreciated. Thank you for your time and help.[/quote]
Here u need to see how far the changes have been made, as Mr Graham said. As per WHO TRS 937 “5.2.5 Validation should be performed:
— for new premises, equipment, utilities and systems, and processes and
— at periodic intervals; and
— when major changes have been made.
(Periodic revalidation or periodic requaliﬁ cation may be substituted, where
appropriate, with periodic evaluation of data and information to establish
whether requaliﬁ cation or revalidation is required)”.
Depending on the function and operation of the equipment, utility
or system, only installation qualiﬁcation (IQ) and operational qualiﬁcation
(OQ) may be required, as the correct operation of the equipment, utility or
system could be considered to be a sufﬁ cient indicator of its performance.
Major changes like Installation at new plant require Full requalificaton.