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GUIDANCE DOCUMENT

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex May 2021

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2018-D-1609
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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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If unable to submit comments online, please mail written comments to:

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1609.

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