COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES

  • S. Mohidekar
  • V. Maharao
  • J. K. Badjatya
DOI https://doi.org/10.22270/ijdra.v2i2.125

Abstract

Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impurities in Drug substance and Drug product, Container-closure. Common deficiencies are presented in this article.

Keywords: Deficiencies; starting material; Impurities; ICH CTD.

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References

1. Edqm.eu [Internet]. Strasbourg: Certification of Substances Division; 2012 June [updated 2011; cited 2014 April 20]. Available from:
http://www.edqm.eu/site/paphcep_12_15pdf-en-30964-2.html
2. GphAonline [Internet]. Washington, DC: Generic Pharmaceutical Association; 2014 [updated 2014 March 24; cited 2014 April 24]. Available from:
http://www.gphaonline.org/media/cms/Enhancing_ANDA_Submissions-A_GPhA_White_Paper.pdf
3. apps.who.int [Internet]. Geneva: World Health Organization; 2014 [updated 2014; cited 2014 April 27]. Available from:
http://apps.who.int/prequal/trainingresources/pq_pres/4_PQ_AssessmentTraining/2-2%20Common%20 FPP%20deficiencies.ppt
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How to Cite
1.
Mohidekar S, Maharao V, Badjatya JK. COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES. Int J Drug Reg Affairs [Internet]. 2018Feb.12 [cited 2025Mar.20];2(2):5-. Available from: https://www.ijdra.com/index.php/journal/article/view/125
Issue
Vol 2 No 2 (2014): VOLUME 2, ISSUE 2, 2014
Section
Review
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