Is validation required

GOOD VALIDATION PRACTICE (cGVP)
1

Process uses a vacuum oven as a storage unit.

conainer with product is placed into the oven…pressurized with some gas for some time before moving onto the next step.

The oven is not used for sterilziation or deprogenation but as a pressurized storing point until the next step.

Does the oven require IOQ validation? Can a calibration of the unit suffice?

2

Does storage in the chamber affect quality? If yes, then I would think validation would be necessary.

How do you know that the chamber remains pressurized at the range of setpoints over the range of times? Does it matter? If so, then again, validation would likely be necessary.