Sigrid Guhr, AbbVie, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Elfriede Maus, AbbVie Deutschland GmbH, Germany
Dr Bettina Pahlen, Quality x Pharma Consulting GmbH, Germany
Jef van Schuerbeek, Consulting bvba, Belgium
During this Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and IMP Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.
Not only in the manufacturing of marketed products (c)GMP Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And what is the role of ICH Q8, Q9 and Q10?
Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.
This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.
This course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control and Regulatory Affairs.
Global GMP Requirements from Phase 1 to Scale-up and Transfer
IMPs in the Context of ICH Q8, Q9 und Q10
- Global requirements: applicable law, directives, guides and guidelines: what is really required
- A comparison of FDA and European requirements and expectations
Important Documents in Pharmaceutical Development
- How to integrate Quality by Design
- Risk Analysis in pharmaceutical development
- Life cycle concept
- Early documentation
- PSF: style and content
- Case studies
Packaging and Supply of Clinical Trial Materials
- From method development to method validation
- How to deal with genotoxic and other impurities
- Quality control and IMP release
- Analytical Qualification
Change Control in Pharmaceutical Development and IMP Manufacturing
- GMP requirements
- Quality control of packaging and labelling
- Handling and sourcing of comparators
- Randomisation and blinding
IMP Manufacturing: how much Qualification and Validation is needed?
- What is required
- What is important
- What are the benefits
- How to implement
The FDA Pre-Approval Inspection (PAI)
- 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 Role of the QP in Pharmaceutical Development and IMP Release
- 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 GMP/GCP Interface
- Co-operation with Head of Production and Head of Quality Control
- Confirmation of Compliance, certification and batch release
- Complaints and recalls
- Pre-requisites for randomisation and blinding
- Site-to-site transfers
- Shelf life extension
- The QP: where does the responsibility end?
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?
- How to handle Deviations in an R&D Environment
- How to implement a Cleaning Validation in Pharmaceutical Development