Petra Barth, form. AbbVie
Buket Hekiman Bayraktar, PharmaVision
York Moeller, J.A.Moeller Chongqing, China
Mukesh Patel, CommQP
Philipp Reusch, Reusch Attorneys
Dr Franz Schönfeld, GMP Inspector, Government of Upper Franconia
Dr Reto Theiß, Merck KGaA
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.
Programme pre-course Session: What you need to know about suppliers in China and India
Sourcing from Asia : what Procurement and QA should know
India and China: cultural Aspects to consider when doing Business
- Trading company or manufacturer – how do I know?
- Different manufacturing sites – was the right one audited?
- Transport Qualification
- Typical GMP Issues of Chinese plants
- What to consider when auditing a plant
The Indian and Chinese Pharma Market: an overview (legal structures, authorities)
- Meeting people for the first time - what to do and what not to do
- Guanxi - Chinese word for “relationship” -
- relationship vs contract
- How are decisions made inside companies
- How to find out who is really in charge
- The Translator - noticing limits
- Overview about size and number of companies
- What documents make a company legal
- What different form of companies do exist
- CFDA - what are their powers, what are their limits
- The Chinese Tax and VAT system and its effect on purchases from China
a) Supply Chain Risk Assessment for China
b) Auditing in India
Challenges and pitfalls
What to look for
Infrastructure and Transportation issues
Programme Efficient Supplier Qualification
The Objective of Supplier Qualification
International Trade Relations – what you need to know
- Regulatory background
- Duties and responsibilities of the QP
- Expectations of the authorities
- Importing Active Pharmaceutical Ingredients into the European Union
GMP pre-requisites for Procurement and Outsourcing Activities
- International trade law
- Applicable commercial legislation
Outsourcing to Contract Manufacturers and Laboratories - what needs to be considered and who is responsible?
- GMP training for procurement staff
- Dealing with brokers
- Change Control
- Roles and responsibilities
Efficient CMO Selection and Qualification
- What activities can you out-source?
- Differences when outsourcing within the EU compared to outside of the EU
- Initiation and Contents of the Technical Agreements
- Validation activities: tasks and responsibilities
- GMP/GDP interface
- Legal and ethical responsibilities
- What can happen when things go wrong?
- CMO assessment criteria
- Project management for outsourced activities
- Knowledge management
- Technology transfer assessment
- Essential agreements
A modular System for qualifying and maintaining Suppliers
Reduced Testing of supplied APIs and Excipients
- Integrating supplier qualification in the pharmaceutical quality system
- Interfaces with other departments
Workshops on Risk Management in the Supply Chain
- 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
A risk based Approach to Supplier Qualification
- When things go wrong: Quality Risk Management to avoid delivery bottlenecks and drug shortage
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
- Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the audit program
- Compliance risk assessment