EU GMP-Production – Quality Made in Germany you can rely on

3. June 2021

89% of the population is convinced that pharmaceuticals they get in Germany are safe and of high quality. Hardly any other type of product is monitored so strictly and seamlessly – from its production at the manufacturer to its sale in the pharmacy.

The European Commission has published principles and guidelines of good manufacturing practice (GMP) to permanently ensure a high quality of pharmaceuticals produced as well as of active pharmaceutical ingredients (APIs). In Germany, the application of GMP in the production of pharmaceuticals and active ingredients is regulated in the “Arzneimittel- und Wirkstoffherstellungsverordnung” (AMWHV). However, these guidelines do not cover excipients.

In the early 2000s, the team of the IOI Oleo GmbH Pharma Business Unit asked themselves:

What is the reason why  principles and guidelines for active ingredients do not apply to excipients?

Pharmaceutical excipients are used in medicines for shaping, manufacturing, controlling the release of active ingredients and improving stability. Many of the substances are characterised and specified in the pharmacopoeia but are not subject to any formal principles analogue to GMP.

In order to show and prove the high quality of the production of excipients at IOI Oleo GmbH, the inspection of the facility in accordance with the GMP standard was requested in 2005. The local German health authority carried out the corresponding inspection and granted GMP certification of the production site in Witten. We are in the fortunate position to produce both excipients and active pharmaceutical ingredients, so that the health authorities carry out regular inspections.

This makes IOI Oleo GmbH one of the first companies with GMP-certified excipients.

But what exactly do the principles and guidelines of Good Manufacturing Practice contain?

The guidelines for the pharmaceutical sector were established by the European Commission, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), the US Food and Drug Administration (FDA) and at the global level by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines serve to ensure the quality of the processes in the production of drugs and active ingredients, because here quality deviations can have a direct impact on the health of consumers.

The quality management in a GMP production must contain the following elements:

  • Document management for specification documents (regular updates and revisions, version logs, tamper-proof storage)

  • Deviation management: definition of processes, procedures and methods must be recorded in specification documents. Deviations and the resulting corrections must be documented and tracked
  • Change management: If processes, procedures or the condition of equipment are planned to be changed, this must be justified before implementation and approved and documented by the quality management
  • Qualification of equipment: It must be shown in a planned and documented process that the equipment is suitable. This is done in four phases:
    • Design qualification (requirements and selection of suitable systems)
    • Installation qualification (on-site installation, completeness check)
    • Functional or operational qualification (checking by means of a function test whether requirements are met)
    • Performance qualification (production of three batches and subsequent testing)
  • Validation of processes and methods: Planned and documented process that shows that the results meet the requirements and are reliably reproducible

  • Training of employees: Appropriate training and corresponding documentation

  • Risk management: identification, analysis, elimination
  • Internal audits: regular checks to a defined extent by trained personnel

Both the renewed GMP certification and the inspection carried out by the US FDA in 2020 underline our claim to only produce the best quality “Made in Germany”.

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René Beyer

René Beyer has been a member of our Pharma team since 2014. As Head of Strategic Sales, his responsibilities include looking after our major industrial customers. With more than 25 years of experience in the industry, René has gained extensive expertise in the areas of Sales, Purchasing and Business Development in different companies. With this background, he is a competent contact partner for all commercial, quality and regulatory questions. For him service is not just a word, but lived practice.