GDP Compliance

EU guidance on good
distribution practice (GDP)

IT Compliance

GDP COMPLIANCE


Today, medicinal product distributors are facing increasing pressure from market competitors and the inexorable advance of digitalisation. This pressure is only likely to increase, which could in turn have an impact on the quality of the product and the safety of its consumers. To mitigate these factors, the European Commission has published revised guidance for good distribution practice for human medicinal products. Switzerland has transposed the guidance adopted by the EU for good distribution practice into its national law, with an amendment dated 1 July 2015 that entered into force on 1 January 2016 following a six-month implementation phase.

The guidance for distribution practice for human medicinal products aims to ensure that both the quality and the safety of medicinal products is guaranteed along the entire distribution chain. The aim is to ensure that counterfeit products cannot enter the legitimate supply chain.


To achieve this, the following criteria must be fulfilled:

  • Necessity of using a Quality Management system
  • The Responsible Person: roles, responsibilities and requirements
  • New requirements for transportation and storage
  • Self-audits
  • Computer system validation
  • Equipment qualification
  • Vendor audits


DHC CONSULTING SERVICES FOR GDP COMPLIANCE

Consulting

GDP compliance check:

We help you to prepare for self-audits or vendor audits by providing you with a tailor-made strategy for your business (including training, audit checklists and final reports).

Computer system validation and equipment qualification:

  • We offer you our services drawn from 18 years of experience in the field of computer system validation and help you to optimise your IT landscape.
  • We provide you with support for the qualification of your equipment to ensure that you achieve conformity with GDP guidance.
Implementation

Setup and optimisation of your Quality Management system:

  • Setup of your QMS, including process description and optimisation.
  • Upgrading of your existing QMS to ensure conformity with ISO 9001:2015 and GDP guidance.
  • Coaching on areas of responsibility and requirements for the Responsible Person.
  • Generation and optimisation of your standard operating procedures (SOPs).
Services & Support

GDP compliance training:

Our training portfolio comprises the topics of GDP compliance, quality assurance, computer system validation and equipment qualification – either on-premise at your business or remotely.

WHY CHOOSE DHC?

Make use of our experience and industry expertise as GDP compliance specialists!

  • 20 years of expertise in IT compliance
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer

 

Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request information!

Learn more about our consulting services for GxP Compliance!

CUSTOMERS

WEBINARS AND EVENTS

08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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