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