Module 3 Presentations

07/05/2024

What is a Specification? Definition

• Specifications are one part of a total CONTROL STRATEGY for the drug substance and drug product designed to ensure finished product quality and consistency.

• Other parts of the control strategy, importantly are:  Critical controls on in-going materials  Critical process parameters (CPP)  Critical starting material / intermediate attributes

ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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When are Specifications set or updated? • First Specification set prior to drug use for first administration to humans (phase 1) • Suitability of specification is kept under review throughout the development process • May revise limits or add an attribute to an existing specification when required  Availability of new data  New regulatory knowledge  When compound transitions from one phase (clinical or development) into another • e.g. from Phase 2 to Phase 3 • e.g. from R&D to registration • Revised specification should be considered when significant change made to synthetic route or the intended drug product is changed.

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

6