Radiopharmaceuticals – Quality, Safety and GMP Requirements

Radiopharmaceuticals – Quality, Safety and GMP Requirements

Vienna, Austria

Course No 15766


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Dr Joël Aerts, University of Paris, France
Dr Istvan Boros, University of Cambridge, Wolfson Brain Imaging Centre, UK
Martin Bradney, Proceutical Ltd., United Kingdom
Robert Hebel, PPH GmbH, Germany
Prof Amir Jalilian, International Atomic Energy Agency, Austria
Mohsen Kamalidehghan, Pars Isotope, Iran
Dr Petra Kolenc-Peitl, University Medical Centre Ljubljana, Slovenia
Dr Jacek Koziorowski, Linkoping University Hospital, Sweden
Dr Oliver Neels, German Cancer Research Center
Dr Gerald Reischl, University Tübingen, Germany
Dr Franz Schönfeld, German GMP Inspectorate Upper Frankonia
Mona Yrvehed, Linkoping Univer


During this conference representatives of regulatory authorities and pharmacopoeial experts will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing establishments.

Furthermore, speakers from nuclear medicine departments from universities and hospitals will share their experiences with GMP implementation. You will become acquainted with possible solutions for the special challenges and practical approaches on room qualification for GMP-compliant manufacturing.

The speaker team is set-up to provide you with the unique possibility to discuss the current status and the future expectations with representatives of national authorities and the International Atomic Energy Agency (IAEA), pharmacopoeial experts as well as professionals from universities, hospitals and engineering.


The manufacturing of radiopharmaceutical products confronts the producing establishment with a collection of challenges. On the one hand, there is the challenge by the contradictory requirements of quality and safety guidelines of pharmaceutical products and the standards of staff safety and radiation protection. On the other hand, there are issues of small batch sizes and short shelf life. The short shelf life necessitates fast transportation and application to the patient. These circumstances mean that classical requirements like sterility testing before release and application cannot be fulfilled.

Target Group

This conference is aimed at the personnel of hospitals, pharmaceutical companies, their suppliers and authorities who are involved in

  • Quality Control
  • Quality Assurance
  • Inspection and Audits
  • Qualification and validation
in radiopharmaceutical manufacturing.


Current Regulatory Developments – Authorities’ View

  • Directive 2001/83/EC
  • Regulation EU No 536/2014
  • EU GMP Guidelines and their annexures 1 and 3
Guidance Documents and further Guidelines – Aspects for Small Scale Preparation/
The Hospital Settings

  • Current good practice for the small-scale preparation of radiopharmaceuticals
  • EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
  • EANM Guidance on Validation and Qualification of Processes and Operations Involving Radiopharmaceuticals
Quality Risk Management – a way to reduce Deviations
  • Deviations as a Routine?
  • Risk Assessment to improve Quality
  • Risk Management Process
Case Study: New Pharmaceutical Production Unit
  • Role of Karaj for Pars Isotope in the past and in future
  • Supplier Selection - National versus International Sourcing
  • Implementation of a Quality System - The Role of VMP
  • Following the V-Model - From Design to Implementation
Production of Ga-68 radiotracers under GMP and regulatory aspects – A German perspective
  • Regulations
  • Technical and practical requirements
  • Setting up a multicenter clinical trial with a Ga-68 radioligand
Radiation Protection in Radiopharmaceutical Production
  • Regulatory requirements
  • General concepts and workflow
  • Constructional realization in a cleanroom environment
  • Waste handling
The Qualification of hot-cells and principal manufacturing equipment
  • An examination of the key Annex 15 qualification elements and how they fit with the Validation Life Cycle
  • The benefits of an integrated validation approach in support of the Project timelines
  • Key considerations to achieve meaningful User Requirement Specifications
  • A risk-based approach to the qualification of principal equipment within the hot cells including the issues arising from multi-qualifications of inter-connected equipment.
The IAEA role in the development of radioisotopes/radiopharmaceutical production and application in Member States
  • The coordinated research program (CRP) mechanisms to initiate product-directed activities
  • The technical cooperation (TC) programs for implementation of technical infrastructure
  • The initiation of technical meetings to focus on the existing challenges in the field
  • Support of the participation of fellows and students in related events
  • Preparation of appropriate publications and TecDocs for global use
Inspections – Experiences
  • The basis for radiopharmaceuticals (PET/TC Generator and Kit)
  • Inspections
  • Typical deficiencies
Bacterial Endotoxin Testing
  • Pharmacopeia methods for endotoxin testing (Ph. Eur. 2.6.14)
  • LAL kinetic chromogenic methodology for rapid detection of endotoxins
  • LAL used for radiopharmaceuticals
  • LAL method validation and data processing
LIMS in Radiopharmaceutical Manufacturing
  • Why LIMS?
  • Obtaining and purchasing a LIMS
  • Escrow agreement
  • IQ/OQ
  • Training
  • Data integrity and GMP compliance.
Cleanrooms for Radiopharmaceuticals: Initial and Periodical Qualifications
  • Regulations: a European Overview at a glance
  • Physical and Microbiological Qualifications
  • An example of a Cleanroom Qualification

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