How to implement the new GDP requirements for APIs

7-8 April 2016, Berlin, Germany

Course No. 15330



Dr Rainer Gnibl, GMP-Inspector for EMA and local Government, Germany
Karl Metzger, gmPlan GmbH, Germany
Dr. Volkmar Schimming, VS Consulting, Germany


This course is intended to provide guidance on the provisions laid down in the new EU GDP guidelines for APIs. You will get to know the key aspects of these guidelines and you will learn about

What has to be considered regarding GDP compliant storage and transportation of APIs
How the exchange of information between agents, traders and pharmaceutical manufacturers should work
Which risk assessment approaches are suitable and should be applied
What authorities expect regarding GDP compliant storage, transportation and distribution of APIs


In March 2015, the “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” were published in the Official Journal of the European Union.

Since September 2015, the provisions of these Guidelines have been obligatory. The driving force behind these Guidelines is the combat against falsified drug substances and drug products. It is intended to control the entire supply chain and thus to mitigate the risk associated with complex distribution pathways. From now on, distributors are required e.g. to have a complete deviation management in place and to maintain a change management system as well as a CAPA system based on risk assessments. Moreover, a GMP-compliant complaint and recall management has to be established and a well trained staff has to ensure that all the requirements of the guidelines are met. In several sections of the Guidelines, it is pointed out that a thorough training of the employees is important.

Target Group

This education course is designed for all persons from companies involved in the distribution and supply of pharmaceutical products. The course will be of interest to managers and executives from the pharmaceutical industry, API manufacturers as well as distributors and traders.


EU Legislation on Distribution of APIs
Directive 2110/83/EC and 2011/62/EU (Falsified
Medicines Directive)
Which authorizations/registrations are required?
Supervisions and sanctions
EU-GDP Guideline for APIs (Overview)
EU-GMP Guideline Part II
Annex 15
Annex 16

GDP compliant storage and transportation of APIs
Which specific requirements are to be implemented?
Risk-based approach for transportation qualification
Supplier qualification

GDP and the role of agents and traders within the
supply chain
Types of intermediates
Key points of an agent’s quality system
Communication and exchange of information with the pharmaceutical manufacturer
Traceability of APIs and how to document it according to the new GDP guidelines
Key aspects of quality agreements

Risk assessment regarding storage and transportation of APIs
Why is it important to perform risk assessments
Risk assessment approaches
What you should avoid when performing a risk assessment

Authority’s expectations and other API GDP topics
Hot spots from EU-GDP Guideline for APIs
Outsourcing of GDP activities
API import: Written Confirmation
QP Declaration
GDP necessary or not?

Conducting GDP audits at API suppliers’ sites –
key points to be considered
Preparing a GDP audit
Key factors of success
GDP audits at suppliers’ sites in Far East –
what has to be considered?
Frequent findings in audits

Implementation of GDP at API manufacturers –
practical experience
Identifying requirements and gaps
Risk assessments
Qualification of facilities, equipment and service providers
Contractual arrangements
Frequent problems and pitfalls

„Quality risk management in API distribution“
In this workshop participants will work on specific cases regarding storage and transportation of APIs
by performing risk assessments for different scenarios and by defining corrective and preventive actions.


This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more

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Please contact us:
Tel.: +49 6221 8444-0

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