In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
GxP (Good Practice guidelines) is an umbrella term comprising various regulatory requirements and standards that have been developed in different areas of the pharmaceutical industry in order to ensure the quality and safety of products in connection with human and animal health. The main objective of GxP is to establish and maintain standards and procedures for various activities such as drug manufacturing (GMP), clinical trials (GCP), pharmacovigilance (GVP), laboratory testing (GLP) and other areas to ensure a high level of quality and safety of products and services.
Below are some examples of best practice in different areas where GxP terms are used:
The overarching goal of all these GxP standards is to protect patients and consumers by ensuring product quality, efficacy and safety (translation into German: Qualität, Wirksamkeit, Unbedenklichkeit) in various areas of healthcare and pharmacy. Among other things, regular audits and inspections by competent authorities ensure that manufacturers comply with these standards.
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