GDP (good distribution practice)

Duration

1-day training and workshop

You will acquire a basic knowledge of the following during this workshop:

  • The regulations that apply within the logistics industry to be able to guarantee good distribution practices (GDP)./li>
  • An overview of the legislation, its development and harmonisation
  • How this legislation is implemented in practice

Why this topic?

Within the (bio-)pharmaceutical, biotech and cosmetic industries, the quality of the manufactured products must be guaranteed at all times.
The rules governing the manufacturing of products to the highest quality standards have already been established for some time now in the sector as Good Manufacturing Practice (GMP) guidelines. There is a growing understanding that this level of quality has to be maintained throughout the onward distribution of medicines to the patient. However, this is no simple matter due to the increasing complexity of the supply chain and the high degree of outsourcing of logistics activities. The new European guidelines on Good Distribution Practice (GDP) of 5 November 2013 set out the rules to help the industry face the latest challenges, such as the rise in counterfeit medicines. The adoption of this regulation by all players involved in the storage and distribution of medicines is increasingly monitored by governments.

What can you expect during the training?

  • You will acquire basic knowledge of GDP expectations and their practical translation on the shop floor.
  • The content of ‘risk assessment’ will be explained using practical examples

What is the result in your daily work?

Knowledge of and acting in accordance with the GDP expectations is essential in order to be able to supply quality products within the pharmaceutical industry. Implementation of the GDP guidelines throughout the entire supply chain is a minimum requirement for all logistics players in the pharmaceutical sector.

Afterwards

  • Participants have a good insight into the requirements of Good Distribution Practices
  • Participants are able to identify the main elements of GDP and establish correct systems in line with these standards

For whom?

This workshop is aimed at all newcomers to the distribution of medicines that want to learn more about the expectations set by governments for the logistics players. Anyone who is directly or indirectly involved in government inspections or customer inspections will also find this workshop useful. No prior knowledge is required.
All participants who attend the complete workshop receive a certificate.

Programme

Introduction in GDP

  • Why GDP?
  • What are the expectations from the government?
  • Who has to be compliant with these GDP guidelines?

The EU GDP guidelinE

  • Principles
  • Quality systems
  • Personnel & training
  • Facilities & equipment
  • Documentation
  • Operations
  • Complaints and recalls
  • Internal audits
  • Distribution of pharmaceutical products

Please note: interactive training

This workshop is interspersed with question-and-answer sessions and practical assignments. To encourage interaction, the number of participants is limited to a maximum of 20.

Find out more about this training via Amelior  or QbDAcademy@qbd.eu.

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