chiragkhatri
★    

India,
2008-01-05 13:01
(6750 d 10:42 ago)

Posting: # 1470
Views: 2,624
 

 ANVISA-application [Regulatives / Guidelines]

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Dear all,
Can someone please clarify the following

"Models of the control files / control records used (temperature of the refrigerators and freezers, room temperature, room humidity, calibration of pipettes, reagents and standards, etc.)

It is mentioned in the application form of ANVISA for approval of bioequivalence facility. It is located on page 7 of the form and document number is 16

For your convenience below is the link to website and file name

http://www.anvisa.gov.br/eng/bio/form_bio_300507.doc

file: Certification for Medicine Bioavailability/Bioequivalence Centers (word)

Regards
Chirag

--
Edit: Link corrected. [HS]
 
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