GMP and Quality Requirements for Radiopharmaceuticals

GMP and Quality Requirements for Radiopharmaceuticals

Vienna, Austria

Course No 20610

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.



ECA-Member*: EUR 1690,--
Non ECA Member*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Clemens Decristoforo, University Hospital Innsbruck, Austria
Jörg Degen, ITM Isotope Technologies Munich
Nic Gillings, Copenhagen University Hospital, Rigshospitalet
Dr Jacek Michał Koziorowski, RadCad
Arjan Langen,  GE Healthcare, The Netherlands
Prof Dr Gerald Reischl, University Tübingen
Dr Franz Schönfeld, Government of Upper Franconia


During this course, representatives of regulatory authorities will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing establishments including the possible impacts of the new Annex 1. Furthermore, speakers from nuclear medicine departments from universities and hospitals as well as from industry 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. They will cover the really “hot topics” in the world of pharmaceutical QA and QC like Qualification, Validation, Monitoring and Good Distribution Practice and more  with a special focus on Radiopharmaceuticals.

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 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 and GDP is a real challenge.

Target Group

This course 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
  •  Radiopharmaceutical Preparation and/or Manufacturing.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.


Regulatory Requirements for Radiopharmaceuticals
  • Directive 2001/83/EC
  • Regulation EU No 536/2014
  • EU GMP Guidelines and their annexes 1, 3 and  13
  • Guidance documents
Annex 1 – Impact on Radiopharmaceuticals
  • Important changes of the revised Annex 1 – from CCS to QRM
  •  Relevant requirements for radiopharmaceuticals
  •  Approaches for implementation
  •  Annex 1 vs. Annex 3
Rooms and Personnel – GMP Requirements for Product Safety
  • Design and qualification of facilities
  • Containment vs. contamination control
  • Training, qualification and monitoring program
QRM Principles – the Modern Way for QA
  • Pharmaceutical Quality System, QRM, and risk assessment(s)
  • Quality Risk Management (QRM) in manufacturing of sterile medicinal products
  • Major changes of Annex 1 (draft) regarding QRM principles
From Equipment Qualification to Process Validation
  • Annex 15 and its key elements
  • How to consider user requirements
  • Equipment and hot cell qualification
  • Process validation requirements
Radiation Protection and Personnel Safety Requirements
  • Regulatory requirements
  • General concepts and workflow
  • Constructional realization in a cleanroom environment
  • Waste handling
IMPD Issues
  • Chemical pharmaceutical data
  • Drug substance
  • Medicinal product
  • Non-clinical pharmacology, pharmacokinetics and toxicology
  • Clinical data
  • Benefits and risks assessment
Requirements on Data Integrity
  • Regulatory Background
  • Quality and manufacturing sections to be adjusted for DI
  • Critical steps in manufacturing
  • DI assessment of computer systems
How to Handle Audits- a Manufacturer’s Experience
  • Hot cell issues
  • Monitoring and Validation
  • Process Validation
  • Data integrity
  • Miscellaneous audit findings over the years.
Microbiological Control – from Sterility to Endotoxins
  • Regulatory Requirements vs. small batch size and short shelf life
  • Challenges and benefits of modern micro methods
  • Parametric Release
  • 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
Supplier Qualification
  • Legal Framework
  • Active pharmaceutical ingredients
  • Supplier selection
  • Supplier Evaluation
  • Approved suppliers
  • Quality Agreement
  • Data integrity
Validation of Analytical Methods
  • Regulatory Background
  • Guidelines and definitions
  • Specific application to Ph. Eur. methods
  • Additional aspects for Radiopharmaceuticals
Cleaning and Disinfection Requirements
  • General GMP requirements on cleaning and disinfection
  • Traditional disinfectants and new methods
  • Validation of disinfection procedures
Monitoring Requirements
  • Regulatory requirements on Monitoring
  • Qualification and routine Monitoring
  • Alert and action levels
  • Trending of data
GDP - a Special Challenge
  • The revised EU Guidelines on Good Distribution Practice (GDP)
  • Who is responsible for maintaining product quality in the supply chain
  • Key challenges and risks to consider
  • Cold Chain and ambient storage and Transportation
  • Role of the Responsible Person (RP)?
  • Special Challenges - Transportation under quarantine status – in bond shipment

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