pravin17
★    

India,
2014-03-19 07:26
(4485 d 02:44 ago)

Posting: # 12663
Views: 3,825
 

 Investigational product destructions of BE studies [Regulatives / Guidelines]

Dear All,

Please guide me for the following
  1. Procedure of destruction of Investigational Product
  2. Is there any specific regulatory requirement or guideline for USFDA, EMEA & CANDA?
Thank You in advance!!
Pravin
drgunasakaran1
★★  
avatar

2014-03-19 15:00
(4484 d 19:09 ago)

@ pravin17
Posting: # 12670
Views: 3,158
 

 Investigational product destructions of BE studies

Dear Mr Pravin,
Routinely, the procedure for destruction of Investigational product will be outsourced to Govt. approved Biowaste Management Agency in India.

Biowaste Management Agencies will have their Standard Operating Procedures for disposing Drugs and Investigational products.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
pravin17
★    

India,
2014-03-25 06:25
(4479 d 03:44 ago)

@ drgunasakaran1
Posting: # 12698
Views: 3,101
 

 Investigational product destructions of BE studies

Thank You Sir!

Pravin Borde
Dr_Dan
★★  

Germany,
2014-03-25 10:15
(4478 d 23:54 ago)

@ pravin17
Posting: # 12702
Views: 3,084
 

 Investigational product destructions of BE studies

Dear Pravin
Please ensure that drug accountability was performed correctly and ensure that you get a certificate of destruction for the IPs. Then everything should be all right in case of inspection.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
pravin17
★    

India,
2014-03-26 08:29
(4478 d 01:40 ago)

@ Dr_Dan
Posting: # 12711
Views: 3,047
 

 Investigational product destructions of BE studies

Thank You Sir!

Pravin
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