Global GMP Requirements from Phase 1 to Scale-up and Transfer
- Global requirements: applicable law, directives, guides and guidelines: what is really required
- A comparison of FDA and European requirements and expectations
IMPs in the Context of ICH Q8, Q9, Q10 and Q12
- How to integrate Quality by Design
- Risk Analysis in pharmaceutical development
- Life cycle concept
Important Documents in Pharmaceutical Development
- Early documentation
- CTD
- PSF: style and content
- Case studies
Analytical Development (ICH Q14)
- From method development to method validation
- How to deal with genotoxic and other impurities
- Quality control and IMP release
- Analytical Qualification
Packaging and Supply of Clinical Trial Materials
- GMP requirements
- Quality control of packaging and labelling
- Handling and sourcing of comparators
- Randomisation and blinding
Change Control in Pharmaceutical Development and IMP Manufacturing
- What is required
- What is important
- What are the benefits
- How to implement
IMP Manufacturing: how much Qualification and Validation is needed?
- Qualification vs. Validation
- What can be found in the regulations
- DQ/IQ/OQ of equipment
- Cleaning validation vs. cleaning verification
- How much process validation is needed?
The FDA Pre-Approval Inspection (PAI)
- Involvement of the R&D Department
- What the FDA will look for
- What happens at FDA during and after the PAI
- Responding to FDA after the PAI
The Role of the QP in Pharmaceutical Development and IMP Release
- Responsibilities
- Co-operation with Head of Production and Head of Quality Control
- Confirmation of Compliance, certification and batch release
- Comparators
- Complaints and recalls
The GMP/GDP/GCP Interface
- Reconstitution
- Pre-requisites for randomisation and blinding
- Distribution
- Site-to-site transfers
- Shelf life extension
- The QP: where does the responsibility end?
Interactive Sessions:
1. Transition of GMP Requirements from Phase 1 to Phase 3 and the Interface to Development Work
- Challenges and Differences
- How to apply phase appropriate GMPs
- Managing a GMP Lifecycle
2. Stability Studies throughout the Development of a new Product
- Different types of products in CT studies (and support)
- APIs and various dosage forms
- Late stage stability strategies
3. Data Integrity
- Manufacturer’s understanding of data integrity, needs and benefit
- Regulatory expectations
- Hybrid systems (paper and electronic records) - how to ensure data integrity?
You will be able to attend 2 of these parallel sessions. Please choose the ones you like to attend when you register for the course.
Case Studies:
- How to handle Deviations in an R&D Environment
- How to implement a Cleaning Validation in Pharmaceutical Development