Efficient Supplier Qualification & Pre-course Session: What you need to know about suppliers in China and India

Im Auftrag der European Compliance Academy

Programm

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
Jurisdiction
Incoterms

GMP Pre-requisites for Procurement and Outsourcing activities
GMP training for procurement staff
Dealing with brokers
Contracts
Change Control
Complaints
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?
Practical execution

Regulatory Inspections
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
Pharmaceutical Artwork
Artwork Origination
Recalls
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
Supplier
Communication from specification setting to
Complaint Handling
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
Examples

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?
Transport Qualification
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