Hello Experts,
We are working on an ANDA for sterile Injectable dosage form and looking for some information regarding glass delamination study.
- Is glass de lamination study for each and every strength (or fill volume) is required if the MOC and vendor of the glass vials are same?
- Is it will be accepted by the agency if we perform bracketing approach on both control sample and product?
- Can stress study or a single stability sample study justifiable to ensure compatibility of my formulation with glass vials?
- Where do you put glass delamination protocols and reports in the eCTD, 3.2.P.2.?
Looking forward to hear your opinion on this topics.
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SUJAN BOSE
Senior Executive
Global Regulatory Affairs (Drugs)
SPPLC. (Bangladesh)
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