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Dr Johanna Eisele, Evonik Industries AG, Germany
Kevin McGlue, Colorcon, UK
Siegmund Kunz, Corden Pharma, Germany
Karl Metzger, gmPlan GmbH, Germany
This course is designed to explain the particularities of pharmaceutical excipients manufacturing and distribution and gives an overview on appropriate GMP and GDP for excipients. Specialists from the pharmaceutical industry and excipients manufacturers will share their expert knowledge on all important aspects relevant for producers and users of pharmaceutical excipients.
You will learn
how to consider the requirements of the new guideline on the formalised risk assessment and how to implement them
how suitable GMP and GDP standards for excipients may look like
how to use risk considerations as a key point of supplier qualification
how excipients can be classified and
which auditable standards and certification schemes can be used
In parallel workshops you will elaborate and discuss case studies and 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 and raw materials as well as traders. The course is of particular interest to all those working in quality assurance, quality control laboratories, production and purchasing departments.
Using the Risk Assessment Guideline to ascertain the appropriate excipient GMP
Risk management for pharmaceutical excipients manufacturers - practical examples
In these two workshops the participants will have the opportunity to work on practical examples. The elaborated solutions will be presented and discussed.
Please mark your choice on the registration form.
GMP and GDP for Pharmaceutical Excipients –
Regulatory Aspects and Legal Initiatives
Why do we need GMP for pharmaceutical excipients?
GMP and GDP Guidelines for pharmaceutical
Risks related to distribution of pharmaceutical excipients and the role of traders and brokers
Focus of GMP inspections at excipients manufacturers
Key requirements of the new Guidelines of the formalised risk assessment
Risk Management for Pharmaceutical Excipients Manufacturers
ICH Q9 – Quality Risk Management
How to establish a risk management process
Project Management – from scratch to GMP compliance
Good Storage / Transportation Practice
Suitable GMP for Pharmaceutical Excipient Manufacture
Difficulties in regulating excipients
What is an appropriate GMP for excipients?
Comparison with GMP for APIs (ICH Q7)
GMPs for continuous processing
Key points for distribution controls
Suitable Guidance – IPEC PQG and GDP Guide
Risk-based Excipients Supplier Qualification – a QP Perspective
The Qualified Person’s role in Supplier Qualification
Risk-based excipients classification & qualification requirements
Type and chemical class
Possible impurities & microbiological considerations
Intended use of the excipients
Type and dosage form of the drug product
Audits and the role of the QP
Excipients Certification - Schemes and Auditable Standards
Why excipients certification?
Key principles of the Excipients Certification Project
3rd Party Auditing
Excipient GMP & GDP Certification Scheme
Meeting the Requirements for GMP-compliant
Manufacturing of a Pharmaceutical Excipient –
A Case Study
Key points and minimum requirements of the QA system
Customers’ GMP expectations
Where to start GMP within the manufacturing process
Risk identification and assessment
Auditing and auditable standards
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
Auditing for GMP Compliance
General auditing considerations
Basic requirements for excipient GMP inspections
Quality-critical processing steps
Audit check points
Suitable Guidance for auditing excipient manufacturers – the Joint IPEC-PQG GMP Audit Guideline