FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

  • Palak Govani Master of pharmacy
  • Krupa Bahekar
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kanki
  • Shrikalp Deshpande
  • Maitreyi Zaveri

Abstract

This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.

Keywords: Knowledge-aided assessment & structured applications (KASA), USFDA, Office of Pharmaceutical Quality (OPQ), failure mode, effects and criticality analysis (FMECA)

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References

1. Food and Drug Administration Meeting of the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee; 2018 sep 20.
2. Yu LX, Raw A, Wu L, Capacci-Daniel C, Zhang Y, Rosencrance S. FDA's new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications. Int J Pharm X. 2019 Mar 17;1:100010. doi: 10.1016/j.ijpx.2019.100010. PMID: 31517275; PMCID: PMC6733282..
3. Public Meeting on Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) White Oak Campus Silver Spring, MD19; 2018.
4. Public Meeting on Prescription Drug User Fee Act. Electronic Submissions and Data Standards: 2019.
5. FDA. PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance [Internet]. US FDA; 2004 Sep [cited 2022 Apr 10]. Available from:
https://www.fda.gov/media/71012/download
6. FDA. Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach [Internet]. US FDA; 2004 Sep [cited 2022 Apr 10]. Available from:
https://www.fda.gov/media/77391/download
7. FDA. Guidance for Industry: Q9 Quality Risk Management [Internet]. US FDA; 2006 Jun [cited 2022 Apr 11]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management
8. FDA. Guidance for Industry: Q8(2) Pharmaceutical Development [Internet]. US FDA; 2009 Nov [cited 2022 Apr 12]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development
9. FDA. Compliance Program Guidance Manual: Pre-approval Inspections [Internet]. US FDA; 2012 [cited 2022 Apr 12]. Available from:
https://www.gmp-compliance.org/files/guidemgr/CPGM7346832S508a[1].pdf
10. FDA, Draft Guidance for Industry: Established conditions: reportable CMC changes for approved drug and biologic products. When finalized, this guidance will represent FDA’s current thinking on this topic [Internet]. US FDA; 2015 May [cited 2022 Apr 12]. Available from:
https://www.gmp-compliance.org/guidelines/gmp-guideline/fda-guidance-for-industry-established-conditions-reportable-cmc-changes-for-approved-drug-and-biologic-products
11. FDA, Guidance for Industry Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, 2017. [Internet]. US FDA; 2017 Sep [cited 2022 Apr 12]. Available from:
https://www.fda.gov/files/drugs/published/Advancement-of-Emerging-Technology-Applications-for-Pharmaceutical-Innovation-and-Modernization-Guidance-for-Industry.pdf
12. Standardized Data for Pharmaceutical Quality, Chemistry Manufacturing and Control; Public Meeting - A Notice by the Food and Drug Administration [Internet]. US FDA; 2018 Aug 22 [cited 2022 Apr 12]. Available from:
https://www.federalregister.gov/documents/2018/08/22/2018-18080/standardized-data-for-pharmaceutical-qualitychemistry-manufacturing-and-control-public-meeting
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How to Cite
Govani, P., K. Bahekar, V. Movaliya, K. Vaghela, N. Kanki, S. Deshpande, and M. Zaveri. “FDA’s New Pharmaceutical Quality Initiative: Knowledge-Aided Assessment & Structured Applications”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 1-7, doi:10.22270/ijdra.v10i4.523.