Dr. Ina Bach, Dr. Bach
Dr Johannes Fröhlich, Akroswiss
Dr Felix Kesselring, Bratschi
Dr Remo Studer, Galexis
- Learn and discuss how to manage your distribution activities GDP-compliant.
- Exchange opinions and convey possible solutions to problems addressed in case studies.
- Benefit from the speakers’ experience in industry, authority and legal advice.
Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and stored in various warehouses. Once the WHO has taken the lead with its guidelines „Good Storage Practices for Pharmaceuticals“ (2003) and „Good Distribution Practices for Pharmaceutical Products“ (2010), more and more compliance with good storage, transportation and distribution practice was emphasised worldwide. Another milestone were the EU-GDP guidelines from 2013 with a lot of intensified demands.
For quite a while it was rather unclear how these guidelines are applicable in the non-EU country Switzerland. Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EU-GMP regulation. However GDP was not covered.
Since 1 July 2015, the EU GDP guidelines do also apply for Switzerland (final implementation on January 1st 2016). This was realised through an adaptation of Annex 2 of Ordinance on EstablishmentLicences(Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd).
On 1 January 2019, the revised Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances
(Therapeutic Products Ordinance Package IV) came into force - with some interesting changes.
Holders of an operating license for wholesale activities are obliged to designate a Responsible Person (“Fachtechnisch Verantwortliche Person, FvP)”.
The requirements for a Responsible Person are described in the Ordinance on Establishment Licences.
This course has been designed for employees, specialists and managers from storage, transportation and distribution as well as their colleagues from quality control, quality assurance and production, which are involved in the various processes of drug logistics.
The presentations of this GDP Course will be available for download and your print-out one week before the conference. Note: there will be no print-outs available during the course.
Legal Bases for the Distribution of Medicinal Products
- Swiss Law and European Law
- Act on Therapeutic Products
- Ordinance on Establishment Licences
- European Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP)
- European GDP Guidelines for Active Substances
- Outsourced activities
- Written contract for outsourced activities
Tasks and Responsibilities
- General considerations on GDP in Switzerland
- Legal Basis
- Revision of the Therapeutic Products Act (HMG) and ist effects
- Authorization types
- GDP Requirements
- Quality in the supply chain
- Technically Responsible Person (FvP) - General
- FvP - Delegation
- Responsibility and liability: Terms
- Different kinds of responsibilities
- Administrative responsibility
- Civil responsibility
- Criminal responsibility
- Protection of the Responsible Person
- The Responsible Person in case law
Practical Implementation in Switzerland
- The GDP inspection: preparation and implementation
- Wholesale vs. pre-wholesale: demarcation and similarities
- Transport in accordance with storage conditions: best practices
- Case study: validation of transport routes, qualification of transport vehicles
Storage and Transport: Practical Aspects (Interactive Session)
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis