Seminar Nr. 9080
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Petra Barth, AbbVie
Richard M. Bonner, ECA, formerly with Eli Lilly
York Moeller, J.A.Moeller Chongqing, China
Mukesh Patel, CommQP
Philipp Reusch, Reusch Attorneys
Dr Franz Schönfeld, GMP Inspector, Government of Upper Bavaria
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?
According the EU Guide to GMP [5.26], starting materials should only be purchased from approved suppliers. And 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
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
GMP training for procurement staff
Dealing with brokers
Roles and responsibilities
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?
Supplier qualification in the light of regulatory inspections
How should the company document supplier qualification activities
Acceptance of Third Party Audits
Challenges of the globalisation
Outsourcing to Contract Manufacturers and Laboratories - what needs to be considered and who’s responsible?
What activities can you out-source.
Is there a difference when you outsource within the EU compared to outside of the EU.
Who initiates the Technical Agreements and what should be included.
Who carries out the validation activities and agrees the acceptance criteria
What part of the supply chain is covered by GMP and what is GDP or GCP?
Who has responsibility for what through the supply chain. Is there a difference in legal and ethical responsibilities.
What can happen when things go wrong.
What you need to know about Outsourcing
Legislation and regulatory guidance
Artwork studio audits: typical observations
Outsourcing project: key learnings
Communication as the Key
The Role of Purchasing
Co-operation with QA, Manufacturing and the
Communication from specification setting to
What you need to know about brokers
Case Study: A modular System for qualifying and maintaining Suppliers
Integrating supplier qualification in the
pharmaceutical quality system
Interfaces with other departments
Workshop on Risk Management in the Supply Chain:
Why is a risk based approach to supplier qualification required?
An interactive workshop 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
Pre-course Session: What you need to know about suppliers in China and India
Sourcing from Asia: what Procurement and QA should know
Trading company or manufacturer – how do I know?
Different manufacturing sites – was the right one audited?
Typical GMP Issues of Chinese plants
What to consider when auditing a plant
India and China: Cultural Aspects to consider when doing Business
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
The Indian and Chinese Pharma Market: an overview (legal structures, authorities)
Overview about size and number of companies
What documents make a company legal
What different forms 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
Inspections in Asia
Challenges and pitfalls
What to look for
Infrastructure and Transportation issues