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GMP in the pharmaceutical industry
Summary and further reading
Introduction to process engineering
Route selection and scale up: case study and exercise
Reactive hazards in scaling up: case study and exercise
Design of experiments
Reaction work-up and product isolation
Abatement and waste treatment
Which of the following are drivers for GMP?
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?
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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