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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
History of multilayered packaging dates back to the late 1950s when Procter & Gamble first designed multilayered collapsible tubes for toothpastes. Amine group containing products deforms HDPE on storage, and are incapable of arresting amine odours. Multilayered CO-EX bottles are the best packaging solution for such products. [5]
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
anon, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, May 1999, Food and Drug Administration, Center for Drug Evaluation and Research, Lockhart, H., and Paine, F.A., "Packaging of Pharmaceuticals and Healthcare Products", 2006, Blackie, ISBN 0-7514-0167-6
The Nordic Institute of Dental Materials (NIOM) performs several tests to evaluate dental products in the Nordic countries. In the European Union, dental materials are classified as medical devices according to the Medical Devices Directive. In USA, the Food and Drug Administration is the regulatory body for dental products.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
The Fair Packaging and Labeling Act required all "consumer commodities" to have a label. Under the act, consumer commodities were defined as any food, drug, device, or cosmetic, that is produced or distributed for sale through retails sales/agencies for consumption by individuals or used by individuals for the purpose of personal care.