1. Radiopharmaceutical Production
Good Manufacturing Practices (GMP)
STOP

2. Good Manufacturing Practices (GMP)
Contents
Overview of GMP
GMP Regulations
Presentations on GMP
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.
STOP

3. Overview of 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

4. World Health Organization
GMP Regulations
The regulations are given in these documents
World Health Organization
Quality Guidance
European Union
Guidelines
US FDA
Part GMP General
Part Pharmaceuticals
Part 212 – PET Radiopharmaceuticals

5. GMP Presentations 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

6. Return to Main Menu