Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

C of A [GxP / QC / QA]

posted by M.Vasu – India, 2011-02-17 05:24 (5196 d 05:16 ago) – Posting: # 6638
Views: 7,434

Hi Dr_Dan,

I do agree, this is a registrated and marketed product (reference). As per the IEC approved protocol it was stated that the study will conduct in complince with the GCP. However, i feel as per GCP sec 8.2.16 (C of A of IP's shipped) sponsor has to file C of A.

Regards,
VM

Complete thread:

C of A M.Vasu 2011-02-10 14:14
- C of A Ohlbe 2011-02-10 16:01
  - C of A M.Vasu 2011-02-10 16:18
    - C of A Ohlbe 2011-02-10 22:31
      - C of A Dr_Dan 2011-02-16 11:00
        
        C of AM.Vasu 2011-02-17 04:24
        
        C of A Dr_Dan 2011-02-17 10:26
        
        C of A Ohlbe 2011-02-21 19:09
        
        C of A Dr_Dan 2011-02-22 09:42

Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
113 visitors (0 registered, 113 guests [including 11 identified bots]).
Forum time: 11:40 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us. Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz