There are registered release acceptance criteria for CQAs. There has also been some discussion around the value of separate, additional internal release limits. On the one hand, it is argued that the registered release acceptance criteria are sufficient to protect for change on stability. The counter argument is that those acceptance criteria may not be conservative enough or reflective of current data, and if a calculated internal release limit is tighter, it should be used. A second separate discussion asks if internal release limits should be applied to final drug product only or also to API with an expiration, not retest, period (particularly an API that changes over its shelf life).

The responses to this survey will be used by the AAPS CMC Statistics Community leadership team to present at a 2025 community meeting.

If you have questions, please reach out to Community Chair Jianfang Hu, jianfang.hu@pfizer.com, or Community Secretary Vaneeta Grover, vkgrover@yahoo.com.

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* 1. Does your company uses internal release limits for final drug product?

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* 2. For Drug Product, does your company calculates separate internal release limits when there are registered release acceptance criteria and then release to the tightest?

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* 3. Are you aware if for Drug Product, when an internal release limit is exceeded, how is it treated? i.e. are the actions similar to:

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* 4. Does your company use internal release limits for API?

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* 5. For API, does your company calculate separate internal release limits when there are registered release acceptance criteria and then release to the tightest?

Thank you for participating in this survey!

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* 6. Are you aware if for API, when an internal release limit is exceeded, how is it treated? i.e. are the actions similar to:

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