Dear forum Experts,
We are manufacturing APIs and these are usually packed in HDPE bags by placed white following black food gradeLDPE bags. But some of customers are insisting me to send the material on fiber and Aluminium containers. But we have packed stability samples and retention samples in HDPE containers.
Now my questions are,
1. Do we have to initiate the stability studies by packing the samples in fiber and Aluminium Containers?
2. Our stability data what we have as on now i.e stability samples packed in HDPE containers, can be suitable?
3. We are going to submit the DMF for that product. What necessary actions to be taken to avoid these situations in future.
Kindly help me at earliest to overcome above situations.
Pulla Reddy Karnati.