Answered February 28th, 2012 by Expert:
The answer is dependent upon many factors. The most important is that no change that might negatively impact the package performance should happen without validation review. Examples of such changes are introduction of a new component manufacturer, change of polymer, introduction of a new thermoforming machine, overhaul of a packaging machine, relocation of a packaging line or a change of pack size. Care must be taken so that small, apparently insignificant changes do not accumulate and lead to unvalidated use.
Validation review may lead to full or partial revalidation and should take place regularly at intervals determined by knowledge of the process and usage of the equipment. Likely validation review intervals are in the order of two to five years.
More specific guidance would need a full knowledge of the packaging process, equipment used and the environment in which it is used.