The European Guideline on appropriate GMP for Excipients – an introduction
- History & Scope
- Legal & International context (USP, WHO, other organizations)
- Risk Analysis: GMP-requirements of excipient versus
- GMP-capability of excipient manufacturer
How to perform a formalised risk assessment
- Step-by-Step practical Approach
- Ongoing risk review of excipient manufacturer & supplier
- Embedding the Formalized Risk Assessment in overall context of existing supplier risk assessment
Suitable quality agreements in pharmaceutical excipients supply
- Why quality agreements?
- Objectives and contents of Quality Agreements
- Negotiations of Quality Agreements – who should be involved?
- Quality agreements with distributors and manufacturers
- Quality agreements and commercial agreements
Suppliers, brokers, vendors – how to keep the oversight from supply chain mapping to qualification
- Understand your excipient’s history
- How to get information about excipient supply chains
- What if …
- Rational qualification approaches
Audits at Excipients manufacturing sites
- General auditing considerations
- Basic requirements for excipient GMP inspections
- Quality-critical processing steps
- Audit check points
- Audits at sites in Far East – what has to be considered?
What to do when an audit is not possible (or necessary)
- Do we really always have to audit?
- How to use the formalised risk assessment
- Reliable sources of information
- EXCiPACT™ and other initiatives
Appropriate GMP and GDP for pharmaceutical excipients – authorities’ expectations
- Legal background of the guideline
- Why do we need a European Guideline on a formalised risk assessment of Excipients?
- Consequences of the Guideline
- What does a GMP inspector expect of the Manufacturing Authorisation Holder?
Performing Formalized Risk Assessments on practical examples
In this workshop the participants will have the opportunity to work on practical examples and elaborate risk assessments for various excipients. The elaborated solutions will be presented and discussed.