Module 9 2021

Early in the journey

Consequential conclusions:

• Realisation of attributes of biological products and their variability

• Awareness of serious hazards

• Importance of consistency in manufacture through analysis

• Recognition of need for controls on raw materials, process and facility to reduce risk

• Concept of Quality: using well-controlled ingredients to manufacture a product of consistent standard

• Concept of oversight: the birth of regulation

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Origin of Regulation

Patient safety was and remains paramount

• Regulation is the codified balance between risk, hazard and benefit to the patient • Regulation has evolved as perceptions of risk and hazard have changed • For a biological drug there are safety issues arising from both the product and from its production process

product:

pharmacology

process:

impurities

toxicology

contaminants

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