COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES

  • S. Mohidekar
  • V. Maharao
  • J. K. Badjatya

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
Mohidekar, S., V. Maharao, and J. K. Badjatya. “COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, Feb. 2018, pp. 5-6, doi:10.22270/ijdra.v2i2.125.