Once a Pharmaceutical manufacturing firm agrees to certain principles of quality manufacturing, they need to stick as per such Quality policies and procedures.
-Using alternate equipment in a standard approved manufacturing process is not allowed.The process which is not validated and using of non-qualified equipment or Equipment not fit for purpose or size of manufacturing is totally disagreed. This is a deviation if one agrees or not.
-If one manufactures the product in such conditions it should not be released. Stability is the last consideration of whole process.
This is the reason Stage 2 Process Validation as per latest FDA guidance is used to guide manufacturing companies What, Where, Why & How the equipment as well as Process should be Qualified and Verified to have a State of Control.
-It is not case of "How big that Deviation " is, but it is a case of "Why such Deviation " was carried out on a Equipment which were not qualified for the purpose?
When questions are raised by regulatory authorities you have no choice of disagreements as your batch reports completely deviate from Processing equipment.
Can alternate Process and alternate equipment be used which are not Validated & Verified?