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Hello,
Would greatly appreciate forum's feedback on the following product packaging question:
I have a situation where a sterile parenteral product (pre-filled syringe) is aseptically filled and stoppered, but the plunger rod and backstop assembly and secondary packaging were not performed for registration stability batches, rather, the filled syringes were placed in cartons similar to those planned for commercial configuration. The product is light-sensitive and the outer carton should protect it from light. The ANDA and Q&A guidance documents are confusing requiring 3 batches to be fully packaged as proposed for marketing or one primary batch for parenterals.
Has anybody had any experience with submitting an ANDA for a sterile parenteral product (pre-filled syringe) without secondary packaging batch records? Is it possible to explain in 3.2.P.7 that automated packaging of commercial batches will be performed? What other documentation should be provided in submission?
The packaging equipment is not yet in place. Would FDA be looking for a packaging line upon their PAI?
Thank you.