EU-GMP Guideline Part IV: Overview
- Positioning within EudraLex Vol. 4
- Definition of ATMPs
- Document structure & technical content
- Key messages
Quality Risk Management for ATMPs
- What does QRM mean?
- ICH Q9 Quality Risk Management (Overview)
- Bounderies & Limitations
- Examples from Guideline
Freeze-drying of Vectors in the Light of Update Annex 1
- Annex 1 requirements for lyophilization
- Further regulatory requirements for (non-)viral vectors
- Benefits of freeze-dried viral vector formulations
Aseptic Manufacturing of Cell-based ATMPs (HCGTP)
- Challenges
- Impact of new Annex 1
- Cross Contamination Control Strategy
Environmental Monitoring
- Segregation between Classification, Qualification & Monitoring
- Clean room lifecycle
- Monitoring elements
- Personell & clean room monitoring
Data Integrity of Automated, Decentralised Cell Therapy Production
- DI concept in research-oriented smaller companies
- Computer-assisted manufacturing of therapeutics
- DI issues in testing, release and logistics
- DI questions in the context of inspections
Contamination Control Strategy
- Definition
- Creation of a CCS
- Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing
- Clarification of types of qualification and validation applied in ATMP manufacturing
- supplier qualification
- device qualification
- software validation - (Aseptic) process qualification / Validation
- method Validation
- operator qualification - Regulatory basis
- How are these types used in the ATMP manufacturing - described in a case study for a clinical phase I/II ATMP
Bioassay Challenges
- Principles and regulatory environment of bioassays
- Matrix approach
- Case studies for various types of ATMPs
Batch Release - What to Consider for AT(I)MPs
- EU Regulatory framework
- GMP for AT(I)MPs
- QP batch certifcation