Proactive Approaches to cGMP Compliance: Insights and Key Takeaways from USFDA Warning Letters to Pharmaceutical Industries Between 2019 and 2024-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

Proactive Approaches to cGMP Compliance: Insights and Key Takeaways from USFDA Warning Letters to Pharmaceutical Industries Between 2019 and 2024

Published:2024-08 Issue:4 Volume:19 Page:
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Aglave Gayatri,Yerram Sravani,Patnam Jayasri Devi,Ajmal C. S.,Nizam V. P. Muhammad,Joga Ramesh,Raghuvanshi Rajeev Singh,Srivastava Saurabh

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s12247-024-09857-3.pdf

Reference31 articles.

1. Jain SK, Jain RK. Review of fda warning letters to pharmaceuticals: cause and effect analysis. Res J Pharm Technol. 2018;11(7):3219–26.

2. Rathore AS, et al. FDA warning letters: a retrospective analysis of letters issued to pharmaceutical companies from 2010–2020. J Pharm Innov. 2023;18(2):665–74.

3. Saini C, et al. Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA. J Generic Med. 2022;18(1):32–41.

4. USFDA. PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL. 2024.

5. USFDA. Current Good Manufacturing Practice (CGMP) Regulations. 2023.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370

www.globalauthorid.com

TOP