Posted by
Dawnrays Pharma on Monday, April 20, 2009 5:28:36 AM
What are the differences between GMP guides for
APIs and for MPs?
Batch review and release of
the finished product
APIs:QU
(specified authorised persons)(2.14, 2.22.1)
MPs:QC and the authorised person
(1.2, 1.4, 2.3,6.3, ref to MA)
-Internal audit / self inspection:
Independence, defined scope,
competent people
APIs: -(2.4)
MPs: +-(Chap. 9)
Annual product Quality
Review (supports the decision
for the need for validation):
APIs: +(2.5)
MPs:+(1.5)