Radiopharmaceutical Production Good Manufacturing Practices GMP STOP Good

Radiopharmaceutical Production Good Manufacturing Practices (GMP) STOP

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

Radiopharmaceutical Production GMP Regulations Contents Overview of GMP Regulations Presentations on GMP STOP 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

GMP Regulations Radiopharmaceutical Production The regulations are given in these documents GMP Regulations Contents Overview of 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 STOP

GMP Presentations Radiopharmaceutical Production GMP Regulations Contents Overview of GMP A WHO Powerpoint Presentation on the Aspects of 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 STOP Introduction to GMP Nicholas Buhay

Return to Main Menu