Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Quality Control United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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. The examples in sections I.A and I.B of the ICH Q12 Annexes illustrate how the development approaches described in section III.B.3.a of the ICH Q12 guidance could be applied. The examples describe different development approaches and resulting control strategies to illustrate how they influence the identification of Established Conditions (ECs) and reporting categories. Marketing Authorization Applications could consist of a combination of these approaches. These examples demonstrate that increased knowledge and understanding gained from progressively more extensive development approaches lead to reduction of uncertainty and improved management of risk. As a result, ECs could become less extensive and reporting categories more flexible.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 27 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918350987206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350987206676