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The intent of Standard ISO 22715 is to specify how cosmetic products should be packaged and labeled to maintain a certain level of standards within the cosmetic industry. This standard applies to cosmetic products whether the product is sold or given away. It is one of 26 published standards that are devoted to the cosmetic industry sector. [1 ...
In the U.S., under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, certain accurate information is a requirement to appear on labels of cosmetic products. [6] In Canada, the regulatory guideline is the Cosmetic Regulations. [7] Ingredient names must comply by law with EU requirements by using INCI names. [8]
The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health Service Act; 606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Although the FDA does not have the resources to inspect all cosmetic products on the market, it can issue penalties for various violations involving packaging and labeling. It is the manufacturer's responsibility to make sure that its product is safe for public consumption.
In its Guidance for Industry "Data Integrity and Compliance With Drug CGMP" US-FDA states “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.