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Foundation
Background to Green Chemistry
Introduction to the Pharmaceutical Industry
Pharmaceutical Process Chemistry
Critical Elements
Renewable Resources
Solvents
Guides and Metrics
Solvent Selection Guides
Reagent Guides
Metrics
Solvents
Use of Solvents
Issues Surrounding Solvent Use
Solvent Guides
Solvent Recovery
Alternative Solvents
Telescoping
Solvents: Quiz
Solvents: Study Exercises
Solvents: Summary and Further Reading
Synthetic Toolbox
Route Selection
Base metal Catalysis
Biocatalysis
Multicomponent Reactions
C-H Activation
Carbonylation
C-F Bond Formation
Flow Chemistry
Amidation
Synthetic Biology
CHEM21 Publications
Process Design
Route Selection
GMP
Introduction to Process Engineering
Route Selection and Scale Up: Case Study and Exercise
Process Safety
Reactive Hazards in Scaling Up: Case Study and Exercise
Reaction Work-up and Product Isolation
Design of Experiments
Environmental Legislation
Abatement and Waste Treatment
Life Cycle Impacts
Examining the Life Cycle
The Fate of APIs
Benign by Design
Life Cycle Impacts: Summary and Further Reading
About
Contact
Home
Foundation
Background to Green Chemistry
Introduction to the Pharmaceutical Industry
Pharmaceutical Process Chemistry
Critical Elements
Renewable Resources
Solvents
Guides and Metrics
Solvent Selection Guides
Reagent Guides
Metrics
Solvents
Use of Solvents
Issues Surrounding Solvent Use
Solvent Guides
Solvent Recovery
Alternative Solvents
Telescoping
Solvents: Quiz
Solvents: Study Exercises
Solvents: Summary and Further Reading
Synthetic Toolbox
Route Selection
Base metal Catalysis
Biocatalysis
Multicomponent Reactions
C-H Activation
Carbonylation
C-F Bond Formation
Flow Chemistry
Amidation
Synthetic Biology
CHEM21 Publications
Process Design
Route Selection
GMP
Introduction to Process Engineering
Route Selection and Scale Up: Case Study and Exercise
Process Safety
Reactive Hazards in Scaling Up: Case Study and Exercise
Reaction Work-up and Product Isolation
Design of Experiments
Environmental Legislation
Abatement and Waste Treatment
Life Cycle Impacts
Examining the Life Cycle
The Fate of APIs
Benign by Design
Life Cycle Impacts: Summary and Further Reading
About
Contact
Home
Process Design
GMP
GMP: Self-assessment Questions
GMP: Self-assessment Questions
Which of the following are drivers for GMP?
*
Select All
To speed up clinical trials.
Maintaining patient trust.
To protect IP.
Ensuring safety of products.
Maintaining quality across all batches of API.
To prolong patent life.
What does GMP aim to ensure?
Speed, Identity, Strength, Patents, Quantity
Safety, Identity, Strength, Purity, Quality
Safety, Identity, Solubility, Purity, Quantity
Speed, Input, Strength, Patents, Quality
Speed, Input, Solubility, Purity, Quantity
Safety, Input, Solubility, Purity, Quality
What are the potential implications of GMP failure?
Select All
Patient illness and possibly death due to contamination of medicine.
Poor control of existing symptoms and possibly death due to incorrect dose of medicine.
Prosecution and corporate fines.
Removal of license to manufacture and / or sell that medicine.
Sales restrictions of product.
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Route Selection
Recap of the SELECT Criteria
Application to API Synthesis
Route Selection: Self-assessment Question
Route Selection: Summary and Further Reading
GMP
GMP in the Pharmaceutical Industry
GMP: Self-assessment Questions
GMP: Summary and Further Reading
Introduction to Process Engineering
Why can’t we scale up directly?
Problems that can Occur During Scale-up of Catalytic Reactions: Part 1
Problems that can Occur During Scale-up of Catalytic Reactions: Part 2
Process Economics
Introduction to Process Engineering: Self-assessment question
Route Selection and Scale Up: Case Study and Exercise
Route Selection and Scale Up: Worksheets
Process Safety
Screening Experiments
Scaling Up
Reaction Calorimetry
Process Safety: Quiz
Reactive Hazards in Scaling Up: Case Study and Exercise
Reactive Hazards in Scaling Up: Worksheets
Further Analysis of the T2 Incident & Recommended Reading
Design of Experiments
Some Definitions
The Experimental Design Process
Comparing Traditional Approaches to Experimental Design
Examples of Variables and Responses for a Chemical Process
Main Effects and Interactions
Experimental Designs: Factorial Designs
Experimental Designs: Response Surface Design
Design of Experiments: Summary and Further Reading
Reaction Work-up and Product Isolation
Reaction vs DSP Examples
Work-up and Isolation Techniques
Telescoping
Example of Improved Work-up Process
Reaction Work-up and Product Isolation: Quiz
Reaction Work-up and Product Isolation: Summary and Further Reading
Environmental Legislation
Industrial Emissions Directive (IED)
Water Framework Directive (WFD)
Solvent Emissions Directive (SED)
Montreal Protocol
REACH
Non-governmental Organizations
Abatement and Waste Treatment
Why do we need abatement and waste disposal?
Air Emissions
Liquid Emissions
Solid Emissions
Abatement and Waste Treatment: Quiz
Abatement and Waste Treatment: Summary and Further Reading