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Revalidation of process controls, equipment, batch size, API source, and excipient source is conducted:
a) annually or after changes are made to the manufacturing process
b) after equipment is relocated or significant changes are made
c) when scaling up to a larger batch size
d) when changing API source or manufacturer
e) when changing excipient source or manufacturer
Revalidation of process controls, equipment, batch size, API source, and excipient source is conducted:
a) annually or after changes are made to the manufacturing process
b) after equipment is relocated or significant changes are made
c) when scaling up to a larger batch size
d) when changing API source or manufacturer
e) when changing excipient source or manufacturer
Revalidation of process controls, equipment, batch size, API source, and excipient source is conducted:
a) annually or after changes are made to the manufacturing process
b) after equipment is relocated or significant changes are made
c) when scaling up to a larger batch size
d) when changing API source or manufacturer
e) when changing excipient source or manufacturer