GMP, or Good Manufacturing Practice, refers to a system of quality assurance regulations and guidelines for the production of pharmaceutical products, medical devices, and food products. It ensures that these items are consistently produced and controlled according to established quality standards, minimizing risks involved in manufacturing.
GMP covers all aspects of production, from the starting materials and equipment to the training of staff and hygiene of the manufacturing facility. It requires thorough documentation of procedures, clear definition of manufacturing processes, and validation of critical steps to ensure product quality and safety for consumers.
GMP is crucial in clinical research as it ensures the quality, safety, and efficacy of investigational products used in clinical trials. By adhering to GMP standards, researchers can have confidence in the consistency and reliability of the study materials, which is essential for generating accurate and reproducible results.
Furthermore, GMP compliance is often a regulatory requirement for clinical trials, particularly those intended for drug development and approval. It provides assurance to regulatory bodies, such as the FDA, that the investigational products meet the necessary quality standards, thereby supporting the integrity of clinical research data and potentially expediting the drug approval process.
The Axcellant team recently attended the International Conference on Nuclear Cardiology (ICNC) in Berlin – one of the most important…
Axcellant is pleased to announce the formation of its Advisory Board - a group of distinguished experts in clinical science,…
The FDA and the European Commission are changing the rules of the game simultaneously. The shift is from a single…
Copyright @ 2026 Axcellant