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biobatch size and scale up [Regulatives / Guidelines]

posted by Elena – Macedonia, 2013-09-17 12:06 (4662 d 20:51 ago) – Posting: # 11503
Views: 7,208

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

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