A review on USFDA warning letter and violation observed in Pharmaceutical Industry

  • Posted on: 1 December 2016
  • By: admin

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PharmaTutor (December - 2016)

 

ISSN: 2347 - 7881
(Volume 4, Issue 12)

 

Received On: 02/07/2016; Accepted On: 14/07/2016; Published On: 01/12/2016

 

AUTHORS:
Suleman S. khoja1*, Sohil S khoja1,Parthkumar H chauhan2,Farhad S Khoja3
1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
2Resource person in quality assurance,NAVSARI, Gujarat.
3Registered Pharmacist ,VAPI, Gujarat India.
*premukhoja@gmail.com

 

ABSTRACT: A review on USFDA observation and finding while inspection of pharmaceutical the present review provides some important, significant observation and measure of compliance. USFDA is a regulatory body governing health products which are made (in or outside USA) and marketed in united States of America. Significant deviation from cGMP and significant violation from cGMP for both API Facility and formulations. Strictly compliance requirements under 21 Code of federal regulations
 

 

How to cite this article: Khoja SS, Khoja S, Chauhan PH, Khoja FS;A review on USFDA warning letter and violation observed in Pharmaceutical Industry; PharmaTutor; 2016; 4(12); 33-36

 

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