Dr Johanna Eisele, Evonik Industries AG, Germany
Ralf Gengenbach, Gempex, Germany
Dr Martin Melzer, Chemgineering Business Design GmbH, Germany
Dr Bernd Renger, Immediate Past Chair of the European QP Association; Renger Consulting, Germany
Rico Schulze, GMP/GDP Inspectorate, Germany
This course addresses the principles of appropriate GMP and GDP as laid down in the European Guideline on the formalised risk assessment for ascertaining the appropriate GMP for excipients. It aims to explain how to implement these principles to meet the requirements of the Guideline and the authorities’ expectations. Specialists from the industry and authority will share their expert knowledge on all important aspects with respect to appropriate GMP/GDP for pharmaceutical excipients.
You will learn
- how appropriate GMP and GDP standards for excipients should look like,
- how to perform a formalised risk assessment for pharmaceutical excipients,
- how Quality Agreements between excipients suppliers and customers should be designed,
- how the oversight of complex supply chains can be kept and what to do when an audit is not possible,
- what authorities expect regarding excipients qualification.
In a workshop you will elaborate a risk assessments on practical examples.
According to the EU Directive 2001/83/EC all active pharmaceutical ingredients used in pharmaceutical manufacturing must be produced in compliance with current Good Manufacturing Practice (cGMP). However due to the complexity of the supply chains GMP and GDP requirements for excipients should be appropriate and not simply mirror those developed for APIs. Article 47 of Directive 2001/83/EC provides that “The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients…” These guidelines are referred to in the second paragraph of point (f) of Article 46 of the Directive.
In March 2015 the Commission has published such Guidelines entitled “Guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use” according to which the manufacturing authorisation holders have now to perform a formalised risk assessment of the excipients used in their drug products and of the excipients manufacturer where they purchase the excipients. Based on this a control strategy has to be established in order to manage and mitigate the risks of use of the excipients.
This course addresses to employees and senior staff of pharmaceutical companies and manufacturers of excipients The course is of particular interest to all those working in quality assurance, quality control laboratories, production and purchasing departments.
The European Guideline on appropriate GMP for Excipients – an introduction
How to perform a formalised risk assessment
- History & Scope
- Legal & International context (USP, WHO, other organizations)
- Risk Analysis: GMP-requirements of excipient versus GMP-capability of excipient manufacturer
Suitable quality agreements in pharmaceutical excipients supply
- 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
Suppliers, brokers, vendors – how to keep the oversight from supply chain mapping to qualification
- 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
Audits at Excipients manufacturing sites
- Understand your excipient’s history
- How to get information about excipient supply chains
- What if … Rational qualification approaches
What to do when an audit is not possible (or necessary)
- 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?
Appropriate GMP and GDP for pharmaceutical excipients – authorities’ expectations
- Do we really always have to audit?
- How to use the formalised risk assessment
- Reliable sources of information
- EXCiPACT™ and other initiatives
Workshop: Performing Formalized Risk Assessments on practical examples
- 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?
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.