Bruce Neagle, thankyou for providing an answer, but i specifically need information for stability testing and packaging specifications of Prefilled syringes. If you happen to know any, kindly share the links here.
It depends on whether your syringes are prefilled or not. If they are prefilled stability is based on the formulation (assay, degradation products, and mass balance). If empty, 'stress' is based on 21 CFR part 820 on 'medical devices'.