Fred Bauer, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Dr Rainer Gnibl, EU-GMP Inspector, Local Government
Karl Metzger, gmPlan, Germany
Dr Volkmar Schimming, VS Consulting, Germany
This course is intended to provide guidance on the provisions laid down in the 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.
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
Quality System Elements for API Distributors
- 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
Application of Risk Management Principles in Planning and Surveillance of the API Distribution
- Manufacture, Importation, Distribution – what does your company do?
- Elements of the Quality System for API Distributors
- Technical Standards for Distribution of API
GDP and the role of agents and traders within the supply chain
- Responsibilities, INCOTERMS, QA-Agreements
- Key elements in planning and monitoring distribution routes
- Risk-based qualification of distribution routes/ risk mitigation activities
Conducting GDP audits at API suppliers’ sites – key points to be considered
- 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
Implementation of GDP at an API manufacturer’s site – case study
Authority’s expectations and other API GDP topics
- 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
- Hot spots from EU GDP Guideline for APIs
- Outsourcing of GDP activities
- API import: Written Confirmation
- QP Declaration
- GDP necessary or not?
„Risk Analysis of Transportation Routes – Practical Exercise“
In this workshop participants will work on specific cases regarding transportation of APIs by performing risk assessments for different scenarios.