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Guidelines for Examination

 
 
5.5.2
Repeatability of results of microbiological processes 

In the case of microbiological processes, particular regard should be had to the requirement of repeatability referred to in F-III, 3. As for biological material deposited under the terms of Rule 31, repeatability is assured by the possibility of taking samples (Rule 33(1)), and there is thus no need to indicate another process for the production of the biological material.

 

References

Rule 33(1)