Outline Various Terms Such As Drug Substance, Drug Product, And Finished Products: Medicinal Product Assignments, TCD, Ireland

Introduction

1. Medicinal Product Terms

Outline various terms such as drug substance, drug product, and finished products, and various administration techniques such as enteral, parenteral, topical, etc.

2. Good Manufacturing Practices (GMPs)

Describe the basis of typical GMPs and what they contain. Identify some regulatory agencies that issue GMPs. What global harmonization initiatives exist?

3. Drug Substance Manufacturing

Outline, in simple terms, the manufacturing sequence for a typical chemically derived Active Pharmaceutical Ingredients (API), and for a typical Biopharmaceutical Protein Therapeutics

1. Medicinal Product – Key Product Quality Attributes and Process Parameters

Identify key product quality attributes associated with the administration of enteral, parenteral, and topical products. Describe key process considerations and related testing activities associated with the manufacture of their various constituents in the sequence of drug substance, drug product, and finished product. Identify major validation activities.

2. GMP Compliance Efficiencies

Describe why regulatory authorities inspect a pharmaceutical manufacturer against pertinent GMPs. Compare and contrast specific GMPs for the manufacture of for example drug substance versus finished product (e.g. ICH Q7 versus 21 CFR Part 211). Summarise the GMPs requirement for ‘Validation’.

3. Priority Testing for Drug Substance Manufacturing

For a typical API and biopharmaceutical process identify Key product quality attributes and associated process parameters for priority testing.