Jeffery,
I was hoping for Annual Report based on the below guidance. What did you end up doing?
Cindy
Guidance for Industry CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports, March 2014, Appendix A: Examples of cmc postapproval manufacturing changes to be documented in annual reports if they have a minimal potential to have an adverse effect on product quality, Page # 10.
4. Specifications
4.3. Change in the approved analytical procedure if the revised method maintains the original test methodology and provides equivalent or increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it claims to have or is represented to possess and the acceptance criteria remain unchanged (e.g., change in the flow rate or sample preparation for a high performance liquid chromatography (HPLC) method).
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Cindy Lombardy
Sr. Director, Regulatory Affairs
B. Braun Medical Inc.
Ringoes NJ
United States
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Original Message:
Sent: 27-Jan-2020 10:51
From: Jeffery Low
Subject: FDA 30 Day Notice
Help with QC lab upgrading analytical equipment. Upgrading HPLC to UPLC. 30 Day or Annual Report? And is full validation required or a simple comparison of both systems?
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Jeffery Low
San Diego CA
United States
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