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• GMP is a way of thinking that encompasses everything that has a bearing on quality of the pharmaceutical product. This includes: personnel; premises; equipment; starting materials; processes; quality control; documentation; packaging and shipping.
• By following GMP philosophy and guidelines, a facility aims to ensure that the product will always be of uniform quality and effectiveness.
Contents
• Overview of GMP
• GMP Regulations
• Presentations on GMP
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Radiopharmaceutical
Production
GMP Regulations
Contents
Overview of GMP
GMP Regulations
Presentations on GMP
What is required for GMP?
• A Quality assurance system which includes:
– documentation
• Standard Operating
Procedures
• Records
• Reports
– quality control (QC)
• specifications
– Equipment
• in-process controls
• Validations
(DQ,IQ,OQ,PQ)
• GMP
– Premises
• laboratory planning
• quality of air
(classes A-B-C-D)
• flow of personnel & materials
– Raw materials
• traceability
• release for use
– Personnel
• sufficient staff
• responsibilities
• qualification
• training & retraining
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Radiopharmaceutical
Production
The regulations are given in these documents
GMP Regulations
Contents
Overview of GMP
GMP Regulations
Presentations on GMP
World Health Organization
Quality Guidance
European Union
Guidelines
US FDA
Part 210 - GMP General
Part 211 - Pharmaceuticals
Part 212 – PET Radiopharmaceuticals
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Radiopharmaceutical
Production
GMP Regulations
Contents
Overview of GMP
GMP Regulations
Presentations on GMP
A WHO Powerpoint
Presentation on the
Aspects of GMP
The following are Powerpoint presentations by experts giving overviews of GMP regulations from different perspectives
Introduction to GMP
Pradeep Garg
Introduction to GMP
Nicholas Buhay
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