GxPvaatimuksia
GxPvaatimuksia refers to a set of regulations and guidelines that govern the manufacturing, testing, and distribution of pharmaceuticals, medical devices, and other regulated products. The "GxP" is an umbrella term that encompasses various quality standards, each denoted by a letter or letters, such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP). These requirements are established by regulatory authorities like the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe.
The primary objective of GxPvaatimuksia is to ensure the safety, efficacy, and quality of products that impact
Compliance with GxPvaatimuksia involves implementing robust quality management systems, maintaining detailed documentation, validating processes and equipment,