Module 3 2019

How do we set acceptance criteria? For Example: Specified Impurities

• The presence of impurities in compound x capsules can be attributed to three potential sources:

1. Drug substance impurities introduced with the ingoing drug substance,

2. Degradation products produced during manufacture of the drug product and

3. Degradation products formed during storage of the drug product.

•

(1) Controlled by API specification

• (2) and (3) Controlled by use of a specific HPLC method and the DP Specification

•

Consistent with ICH

The Organisation for Professionals in Regulatory Affairs