GMP Requirements in the EU

To import a pharmaceutical product into the EU you must abide by European GMP (Good Manufacturing Practice) requirements, to make sure that products are manufactured and controlled according to specific quality standards. EU requirements differ from those anywhere else in the world. There is a list of guidelines published by the EMA (European Medicines Agency) and these must be implemented for quality control.

Some of the key principles of these guidelines are:

  • Quality Management
  • Personnel
  • Premises & equipment
  • Documentation
  • Production
  • Quality control
  • Contract manufacturing & analysis
  • Complaints & product recall
  • Self inspection

Additionally, here are some of the key terms and standards to abide by: GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder.

What is Good Manufacturing Practice?

Good Manufacturing Practice (GMP) is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control.

Current Good Manufacturing Practice (CGMP) denotes the “current” aspect of Good Manufacturing Practice, meaning that the manufacturing practices have to be up to date to comply with regulations.

CGMP applies to API, bulk product, IMPs, Finished Product and Excipients based on risk. The principles of CGMP are captured in respect of the premises in which we work, office. It includes all the materials that we use, the people and their competence and their training and qualifications. Everything that we do must be defined very clearly through detailed procedures and all the processes must recorded in detail to meet data integrity requirements.

All these expectations mean that we have a very significant amount of regulation to meet. The basic tenet in which we work is ‘Quality must be built into our products, not tested into our products’. While quality control is a key factor in ensuring release to the market, the quality and consistency of the product also comes from initial Quality by Design (QbD), validation processes and if required successful technical transfers. Testing ensures that product specification is met but will not in itself assure quality.

What is GxP?

The ‘x’ stands for best practice in the area of activity in that part of the supply chain. This can include GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice).

What is Good Distribution Practice?

Good Distribution Practice is the part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public. This is defined within legislation to the EU – (Directive 2001/83/EC), and includes the Falsified Medicines Directive 2011/62/EU – introduced in February 2019.

MIAS Pharma can guide you through the varying EU requirements necessary for EU product release. If you would like to get in touch with us and receive more information about our services, please email or call on +353 (1) 846 3605.

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