Dr Melanie Distl, Roche, Switzerland
York Moeller, J.A.Moeller Chongqing, Germany
Mukesh Patel, CommQP, U.K.
Philipp Reusch, Reuschlaw, Germany
Wolfgang Schmitt, Concept Heidelberg, Germany
Dr Franz Schönfeld, GMP Inspector, Government of Upper Franconia, Germany
Dr Reto Theiß, Merck HealthCare, Germany
During this course, you will learn all relevant aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.
Qualification and audits of suppliers, contract manufacturers and laboratories and other service providers are an important part of each Quality System. But what is required and which steps are really necessary? And is it possible to even decrease audit activities?
Starting materials should only be purchased from approved suppliers. EU Directive 2004/27/EC states that the manufacturer shall only use active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials. But also in contract manufacture and analysis, the contract giver is responsible for assessing the legality, suitability and the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.5]).
The requirements and efforts to qualify suppliers should therefore not be underestimated. However, it seems that a downright ‘audit tourism’ has grown and suppliers and service providers are audited on site frequently and sometimes too often. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings new challenges. This adds up to significant expenses for both the audited and the auditing company.
But supplier qualification is not limited to auditing. The whole process of supplier qualification and co-operation should be integrated in the existing Quality System of a company.
This course and its pre-course session are designed for all personnel involved in supplier qualification activities at their company and decision makers who want to improve the existing process. It is addressed to persons from Quality Assurance and Control, Procurement, Business Development, Manufacturing, Project Management and R&D.
The Objective of Supplier Qualification
- Regulatory Background
- Duties and responsibilities of the QP
- Expectations of the authorities
- Importing Active Pharmaceutical Ingredients into the European Union
International Trade Relations – What you Need to Know
- International trade law
- Applicable commercial Legislation
GMP Pre-Requisites for Procurement and Outsourcing Activities
- Objectives & priorities
- EU GMP Chapters and GMP processes applicable to Procurement
- GMP Training for the Buyer
- Supplier qualification
- Supplier categorisation
- Use of Brokers
Outsourcing to Contract Manufacturers and Laboratories - What Needs to be Considered and Who is Responsible?
- Regulatory Framework
- Outsourcing EU vs non-EU
- What if it goes wrong?
- Outsourcing Life-Cycle Management
- Elements of Supplier Qualification
- Risk Assessment
- Technical Agreements
Examples and Interaction: Quality Risk Management in the Supply Chain
- Expectation of the Regulators
- Risk assessments
- Interactive Session
- Frequency of supplier audits based on risk assessment
Qualifying and Maintaining Suppliers at Roche
- Supplier Management embedded in PharmaTechOps and PQS
- Interface with other Departments
- Example – Risk-based approach to Supplier Management at Roche
Reduced Testing of Supplied APIs and Excipients
- What guidance is available on reduced QC testing?
- EU and FDA expectations
- Information required before you start reducing
- Can APIs and excipients be covered within the same approach?
- Practical execution