Whenever possible software changes should be tested offline prior to installation on the live production plant / system.
When this is not possible, the change should be assessed for its risk to product quality, plant and personal safety
prior to installation. Where the level of change is considered to be low risk, the change may be tested on the live plant /
system without the need to stop routine use / production. for high risk changes the change should be tested when the system plant
is not in routine use.
A[COLOR=“Blue”] change is defined as an action which gives rise to a situation which is different to that observed before the change took place. Changes may take the form of operating parameters, acceptance criteria, documents, materials, equipment, new equipment and facilities or anything else which plays a part in the manufacturing process or could have an impact upon GMP.A like for a like swap eg replacing a worn component with a new item of identical specification is not considered to be a change under this definition. Adjustments within validated limits are not regarded as changes provided they are carried out within written guidelines and they do not change the status of validation.
Any significant change in SOP(s), Specifications, Test Methods, and Batch documents impacting the quality of drug product will be handled through Change Control.
Regards,
Satish Thube[/color]
why is cleaning validation in API?