Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

biobatch size and scale up [Regulatives / Guidelines]

posted by Elena – Macedonia, 2013-09-17 12:06 (4662 d 17:09 ago) – Posting: # 11503
Views: 7,207

Dear all,

I would kindly like to ask for your advice.

According to the CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** "In case of a production batch smaller than 100,000 units, a full production batch will be required."

If the biobatch is < 100,000 units, is scale-up allowed according to EU regulations?

Thank you,

Best regards,

Elena

Complete thread:

biobatch size and scale upElena 2013-09-17 10:06
- Type II Variation Helmut 2013-09-17 16:36
  - Type II Variation Elena 2013-09-18 08:42
    - Type II Variation Dr_Dan 2013-09-18 10:01
      - Type II Variation Ohlbe 2013-09-18 12:41
      - Type II Variation Elena 2013-09-18 12:55

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
131 visitors (0 registered, 131 guests [including 34 identified bots]).
Forum time: 05:16 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution. Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz