Issue Date: May 11, 2021
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
The examples provided in sections I.A through I.F of the ICH Q12 Annexes are mock examples provided for illustrative purposes. They only suggest how the tools described in sections III, IV, and V of the ICH Q12 guidance could be applied, and should not be used as a template or the sole basis for a regulatory submission. In addition, the reporting categories, as described in section II of the ICH Q12 guidance, may differ across regions depending on regional legislation; the nature of the product; and the Marketing Authorization Holder’s (MAH’s) demonstrated understanding of the product, process, and analytical procedure.
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