Tel.: 06221 / 84 44 0 E-Mail: email@example.com
Dr Afshin Hosseiny, Chair of the ECA Expert Working Group on GDP, Tabriz Consulting
Dr Martin Egger, Pharmaserv
Dr Daniel Müller, GMP/GDP Inspector
Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are closely linked. A new GDP Guideline published by the European Commission will bring comprehensive changes for everyone involved in the distribution of Medicinal Products.
The enhanced role of the Responsible Person for GDP will be highlighted at this event. The specific responsibilities and tasks of the Responsible Person will be discussed as well as the close link between QA and the QP of the Medicinal Product Manufacturer.
In 2013, the European Commission’s Directorate General for Health and Consumer Policy (DG SANCO) published the new ‘Guideline on Good Distribution Practice of Medicinal Products for Human Use’. Through its GMP/GDP Inspectors Working Group the European Medicine Agency worked on the revision of the guideline which was first published in 1994.
The guideline was revised to take into account advancements of practices for an
appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council. It is amending Directive 2001/83/EC on the Community code relating to medicinal products for human use with regard to preventing falsified
medicinal products to enter the legal supply chain.
In Chapter 2 “Personnel” defines tasks and responsibilities of the Responsible
Person are defined. This Responsible Person should be continuously contactable. General requirements like organisational chart, job descriptions and training
requirements are new or outlined in much more detail.
The Training Course is of particular interest to management and personnel from Pharmaceutical Companies as well as from Distributors and Service Providers involved in wholesale distribution of medicinal products for human use.
All participants receive a Roadmap to Good Distribution Practice containing:
An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
Checklist for the implementation of GDP principles
The New EU GDP Guideline
The counterfeit directive and Pharma supply chain overview
Regulatory expectation for implementation
Role of the RP in batch release
What does Batch Release mean to a Responsible Person?
Responsible Person (RP) vs. Qualified Person (QP) role in batch release
Basic requirements for the role of Responsible Person (RP) in batch release
Roles and Responsibilities of the Responsible Person
Qualifications requirements for RP
Duties of a RP
How to discharge your duties
Expectations with regard to the Responsible Person
Track and Trace
How can track and trace support anti-counterfeiting requirements
Control temperature distribution
How to manage cold chain products
How to manage 15 - 25 °C requirements
Temperature monitoring or control - what is the best option for the product?
How to plan the audit
Approach to GDP audits
Examples of recent audit findings
Case Study: Management of a GMP warehouse and distribution of medicinal products with a 3PL-Approach
Outsourcing in Pharma Logistics - current trends & benefits
Determining the scope of Outsourcing
Processes, roles & responsibilities
Monitoring of critical data
Reporting of the performance & controlling of the 3PL
The roles and responsibilities of wholesalers
How wholesalers are organised
How to manage different clients and their requirements
Pick and pack - best practices
How to stay in compliance
Roles and Responsibilities of an RP and a QP in a Warehouse and Distribution environment where Value Added Logistic activities, like re-labelling, etc take place.
Responsible Person/Qualified Person
Pharmaceutical versus Nutritional products
Good Distribution/Manufacturing Practice
Product Finishing activities
Product Action, like QA holds
Handling of Returned and Damaged goods
How to manage 3PL service providers
Contracts and monitoring