Radiopharmaceutical Production

1. Radiopharmaceutical Production Good Manufacturing Practices (GMP) STOP

2. 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 Good Manufacturing Practices (GMP) 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. GMP Regulations The regulations are given in these documents World Health Organization Quality Guidance European Union Guidelines US FDA Part 210 - GMP General Part 211 - 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

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