Module 3 Presentations

07/05/2024

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

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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How do we set Acceptance Criteria?

• For Example: Specified Impurities: • The acceptance criterion for UK-123,456 has been established as 0.7% maximum . This acceptance criterion was based on the following considerations:  IMPURITY-123,456 is a potential process related impurity in drug substance. It is controlled by the drug substance specification to 0.4%.  IMPURITY-123,456 does not form during manufacture of the drug product.  IMPURITY-123,456 is qualified to 1.0%  IMPURITY-123,456 is also a potential degradation product of the drug product and has been observed in stress testing studies on the drug substance. Minor changes in the level of UK-123,456 have been observed during drug product stability studies to date. • Accelerated stability studies using high temperature and humidity and quantified using a modified Arrhenius equation (ASAP) show acceptable shelf life at the acceptance criterion of 0.7%

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

12