HCP Limits !

["ambika" <ambika@scigenin.com> (by way of John Dolman<info@the-dolman-consultancy.com>)]

Dear All,

Can anyone guide me how to fix the limits of process related impurities
in Biopharmaceutical products if in the Monograph of the Drug substance,
it is mentioned only that "the limit shall be decided by the
competent authority"

1. Who is the competent authority?

2. What is the procedure of deciding the limits for the process related
impurities?

e.g. For GCSF (Filgrastim conc. solution), the Ph. Eur. mentions
"the limit shall be decided by the competent authority" for
HOST CELL PROTEINS.


Thanks in advance.

Regards,
Ambika.