Inspections – Key Role in Quality of Medicines
Abstract
Global patients depend on medications for their specific purposes. These drugs are manufactured both domestically and internationally. Regardless of where they are manufactured, the Food and Drug Administration (FDA) plays a pivotal role in the United States, regulating drugs, biologics, and devices by not only scrutinizing each marketing holder's application but also guaranteeing that the product's manufacturer complies with current good manufacturing practices (cGMP). This ensures that the product's quality is consistent and is manufactured securely for its intended use.
Downloads
References
2. The drug development process [Internet]. U.S. Food and Drug Administration. FDA; 2018 Jan 04 [cited 2023 Jul 31]. Available from: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
3. Facts about the current Good Manufacturing Practices (CGMP) [Internet]. U.S. Food and Drug Administration. FDA; 2023 May 31 [cited 2023 Jul 16]. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmp
4. Office of Regulatory Affairs. Inspection Observations [Internet]. U.S. Food and Drug Administration. FDA; 2022 Nov 21 [cited 2023 Jul 16]. Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
5. Types of FDA inspections [Internet]. U.S. Food and Drug Administration. FDA; 2023 May 15 [cited 2023 Jul 16]. Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-basics/types-fda-inspections
6. Conducting remote regulatory assessments [Internet]. Fda.gov. 2022 Jul [cited 2023 Jul 21]. Available from: http://www.fda.gov/media/160173/download
7. What to Expect on FDA Inspections [Internet], Fda.gov. 2020 Sep 29 [cited 2023 Jul 30]. Available from: http://www.fda.gov/media/142762/download
8. Schmitt S. The value of FDA 483s and warning letters [Internet]. Pharm Tech. 2021 Jul 02 [cited 2023 Jul 14]. Available from: https://www.pharmtech.com/view/the-value-of-fda-483s-and-warning-letters
9. FDA Form 483 frequently asked questions [Internet]. U.S. Food and Drug Administration. FDA; 2022 Jan 09 [cited 2023 Jul 14]. Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
10. Inspections Database frequently asked questions [Internet]. U.S. Food and Drug Administration. FDA; 2020 May 11 [cited 2023 Jul 14]. Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions
11. FDA dashboards - inspections [Internet]. Fda.gov. [cited 2023 Jul 21]. Available from: https://datadashboard.fda.gov/ora/cd/inspections.htm
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.