The search results provide information on the control of components and drug product containers and closures, pharmaceutical quality control laboratories, in vitro diagnostic device labeling requirements, COVID-19 Ag rapid test device, WHO guidelines for sampling of pharmaceutical products and related materials, and formulation ingredients for toothpastes and mouthwashes. Below are the details on the control of product details, positive, negative, ingredients, or materials:
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Control of components and drug product containers and closures: The FDA requires that animal-derived ingredients be controlled to ensure that contamination does not occur, beginning with initial collection. The identity of a component is generally a discrete variable, and the component containers content might differ from what the container label states due to mistakes in filling and labeling by the supplier or repacker, or as a result of the substitution of a containers contents during distribution and warehousing before receipt by the drug product manufacturer. Quality control measures, including the setting of specifications, sampling, testing, and analytical clearance, are taken to ensure that raw materials, intermediates, packaging materials, and finished pharmaceutical products conform with established specifications for identity, strength, purity, and other characteristics.
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In vitro diagnostic device labeling requirements: The labeling requirements for in vitro diagnostic devices include a statement indicating the presence of and characterizing any catalytic or nonreactive ingredients, the common name, quantity, proportion, or concentration of each reactive ingredient, and appropriate cautions or warnings. The labeling should also include details of necessary quality control procedures and materials, such as positive and negative controls and acceptable performance limits.
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COVID-19 Ag rapid test device: The test device has a test line and a control line on its surface, and the control line is used for procedural control and should always appear if the test procedure is performed properly and the test reagents of the control line are working. The device also includes external quality control measures, such as positive and negative controls, to verify the users ability to properly perform the test and interpret the results.
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WHO guidelines for sampling of pharmaceutical products and related materials: These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities, quality control laboratories, and customs and police authorities responsible for the clearance of drug products held in quarantine after manufacture or importation. The guidelines provide information on the sampling of pharmaceutical products and related materials, includin...