GMP meets Development
Im Auftrag der ECA Academy

Programm

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 und Q10

• 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

• 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/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?

Case Studies:

• How to handle Deviations in an R&D Environment
• How to implement a Cleaning Validation in Pharmaceutical Development