Nice numbers [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-21 15:05 (951 d 01:10 ago) – Posting: # 18944
Views: 6,066

Hi Beholder,

» But why did FDA deside to use 1/10 or 100,000 rule? […] 100,000 is just round number and that's all?

We find nice numbers which are “easy to remember” everywhere.See also the BE GL Section 4.1.2
  1. The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified.
  2. The production of batches used should provide a high level of assurance that the product and process will be feasible on an industrial scale.
    In case of a production batch smaller than 100,000 units, a full production batch will be
    required.
(my emphasis)

prod. scale  full batch    10%    rule  biobatch
    50,000      yes        5,000    b     50,000
   100,000       no       10,000    a    100,000
 1,000,000       no      100,000    a    100,000
 5,000,000       no      500,000    a    500,000


Duno which justification you could give for a smaller biobatch under condition a).

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Helmut Schütz
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