Module 9 2021

For biologicals in particular

• Control of raw materials for endogenous and adventitious agents and validation of process capability to remove and/or inactivate such contaminants is a key part of biologicals development

• The guidance is now mature and the technology sufficiently well understood to have become routine

• But there complexities and careful evaluations of strategy required

Virus Safety and TSEs Anne Stokes

The Organisation for Professionals in Regulatory Affairs

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For biologicals in particular

• The concept of product comparability is now established and supported by comprehensive technical guidance

• Even so, the case by case basis approach must be taken in evaluating process change, consequences for the product and the subsequent demonstration of new product comparability with old • The infinite variety of comparability scenarios cannot be covered by an infinite repertoire of guidance, so cerebral interpretation is required

The Organisation for Professionals in Regulatory Affairs Implications and Regulation of Changes During Process Development Rhydian Howells

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