GMP (good manufacturing practices)

Duration

1-day training and workshop

During this workshop, you will acquire a basic knowledge of the following:

  • The regulations that apply within the pharmaceutical industry to be able to guarantee good manufacturing practices (GMP).
  • An overview of the legislation, its development and harmonisation
  • How this legislation is implemented in practice

Why this topic?

Within the (bio-)pharmaceutical industry, the quality of the manufactured products  must be guaranteed at all times. In the past, a number of rules or good practices were developed in this regard, by both legal authorities and the sector itself. Vigilance and continuous improvement of processes as well as in the development of drugs are required.

In practice, establishing and introducing these good manufacturing practices is not easy. Specific knowledge is required to introduce and maintain this way of working. All employees should be familiar with GMP expectations and act accordingly.

What can you expect during the training?

  • You will acquire basic knowledge of GMP expectations and their practical translation on the shop floor.
  • The content of the ICH GMP guidelines will be explained using practical examples.

What is the result in your daily work?

Knowledge of and acting in accordance with GMP expectations is a requirement in order to deliver high-quality products within the pharmaceutical industry.

Afterwards:

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

For whom?

This workshop is intended for anyone who has recently started in the pharmaceutical industry and wishes to learn more about the expectations placed on the goods produced according to GMP. No prior knowledge is required.

All participants who attend the complete workshop receive a certificate.

Programme

The concept of ‘quality’ within the pharmaceutical industry

Standards and norms

  • Pharmaceutical legislation
  • Inspections and authorities
  • Drug registration

ICH GMP content, meaning and requirements

  • Principles
  • Division of ICH GMP guidelines
  • Requirements placed on employees and resources
  • Requirements placed on production and controls
    • Production and packaging
    • Laboratory
    • Warehouse, storage, distribution
    • Validation and change management
  • Requirements placed on documentation and records
  • Complaints and recalls
  • Internal audits
  • Other expectations

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 15.

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

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