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Extrusion in food processing consists of forcing soft mixed ingredients through an opening in a perforated plate or die designed to produce the required shape. The extruded food is then cut to a specific size by blades. The machine which forces the mix through the die is an extruder, and the mix is known as the extrudate. The extruder is ...
Article 57 of the Regulation requires that the TMF "shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated", confirming that the trial master file should be maintained contemporaneously.
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research.The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
Melt blowing is a conventional fabrication method of micro- and nanofibers where a polymer melt is extruded through small nozzles surrounded by high speed blowing gas. The randomly deposited fibers form a nonwoven sheet product applicable for filtration, sorbents, apparels and drug delivery systems.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Because food science is a multi-disciplinary field, food physical chemistry is being developed through interactions with other areas of food chemistry and food science, such as food analytical chemistry, food process engineering/food processing, food and bioprocess technology, food extrusion, food quality control, food packaging, food ...