Transcript GMP

Radiopharmaceutical Production
Good Manufacturing Practices (GMP)
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Good Manufacturing Practices
(GMP)
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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
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Overview of GMP
GMP Regulations
Presentations on GMP
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Overview of GMP
Radiopharmaceutical
Production
GMP Regulations
Contents
Overview of GMP
GMP Regulations
Presentations on GMP
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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)
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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
GMP Regulations
Radiopharmaceutical
Production
The regulations are given in these documents
GMP Regulations
Contents
Overview of GMP
GMP Regulations
World Health Organization
Quality Guidance
Presentations on GMP
European Union
Guidelines
US FDA
Part 210 - GMP General
Part 211 - Pharmaceuticals
Part 212 – PET Radiopharmaceuticals
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GMP Presentations
Radiopharmaceutical
Production
GMP Regulations
Contents
Overview of GMP
A WHO Powerpoint
Presentation on the
Aspects of GMP
GMP Regulations
Presentations on GMP
The following are Powerpoint presentations by experts giving
overviews of GMP regulations from different perspectives
Introduction to GMP
Pradeep Garg
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Introduction to GMP
Nicholas Buhay
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