GDP in Switzerland - Specifics in the Distribution of Medicinal Products

GDP in Switzerland - Specifics in the Distribution of Medicinal Products

Bern, Switzerland

Course No 16432


Costs

4 September 2018: EUR 1090,--
GDP Association Members: EUR 990,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Ina Bach, Dr. Bach AG
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG Lawyers
Dr Johannes Fröhlich, Akroswiss
Dr. Remo Studer, Galexis AG

Objectives

  • 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

Background

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 Establishment Licences (Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd)

Target Group

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..

Participants‘ comments:

“Very good course”
Igor Todorcevski, Alkaloidpharm SA
“Very useful presentations! Thank you!”
Dr. Thorsten Dedecke, Fresenius Medical Care (Schweiz) AG

Programme

EU Regulations and their Implementation in Switzerland

  • Legal basis in Switzerland including EU regulations
  • The Ordinance on Establishment Licences OEL (AMBV, OAMéd)
  • GMP/GDP Interface
  • Working with contractors
Practical Implementation in Switzerland
  • The GDP Inspection: what do inspectorates expect and how to prepare
  • Wholesaler vs. Pre-Wholesaler: interfaces and delimitation
  • Transport at storage conditions: best practices
  • Case Study: transport validation
Tasks and Responsibilities
  • Requirements and due diligence for the Responsible Person according Art. 9 and 13 of the Ordinance on Establishment Licences
  • Storage and distribution: current expectations
  • Qualification of suppliers and recipients
  • Senior Management
  • Responsible Person
Cross-border Distribution: Requirements for Import and Export
  • Relevant requirements for import and export
  • International Distribution: EU, EEC and MRA, Third Countries
Storage and Transport: practical Aspects
a) Warehouse
  • Requirements
  • Qualification
  • Mapping
  • Hygiene
  • Documentation
b) Transport
  • Transport qualification/ validation
  • Transport at ambient conditions: expectations and control
  • Deviation management
  • Cool and cold chain
Liability
  • Principles of liability
  • Who is liable?
  • Potential sanctions
  • Examples from the real life, case law

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