GMP (Good Manufacturing Practice)
What is GMP?
GMP refers to "Good Manufacturing Practice" and plays an important role in pharmaceutical water treatment. In the EU, manufacturers of medicinal products and active ingredients are obliged to comply with the current EU GMP Guideline when manufacturing, processing, testing, packaging and storing drugs and pharmaceutical ingredients.
More precisely, it is a set of standards, principles and requirements published by the European Commission. For example, the EU GMP Guideline define how pharmaceutical manufacturers should organise and run their operations to ensure compliance with quality standards and guarantee the safety of their products. The aim of the guidelines is to ensure that patients can rely on medicines always meeting the same high-quality standards.
What are the latest developments?
The World Health Organisation (WHO) has published the tenth edition of its GMP Compendium in 2024, which includes a fundamental revision and expansion of guidelines for pharmaceutical manufacturing and monitoring. This new version includes updated guidelines that consider new challenges in the pharmaceutical industry and outline more advanced approaches to manufacturing practice. In particular, new guidelines for the manufacture of radiopharmaceuticals and medical gases are emphasised, as well as greater focus on the use of evidence-based and risk-managed approaches.
What is the difference between GMP and GAMP?
While GMP defines the general standards for the manufacture of pharmaceuticals and related products, GAMP (Good Automated Manufacturing Practice) contains specific guidelines for the use of automated systems in manufacturing, particularly in areas such as pharmaceuticals, biotechnology and related industries.
It defines specific requirements for risk assessment, system validation and continuous compliance for computerised systems. The GAMP guideline provides a framework and guidance for the validation, operation and maintenance of automated systems to ensure that they fulfil GMP requirements.