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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.
ASTM D7387- Standard Test Method for Vibration Testing of Intermediate Bulk Containers (IBCs) Used for Shipping Liquid Hazardous Materials (Dangerous Goods) ISO 16104 - 2003 Packaging - Transport packaging for dangerous goods - Test methods; Soroka, W, "Fundamentals of Packaging Technology", IoPP, 2002, ISBN 1-930268-25-4
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
The ISO 22715 standard Cosmetics — Packaging and labelling provides guidelines for manufacturers in the best practices for cosmetic packaging and labelling of all cosmetic products. This standard applies to products that fall under the category of cosmetics that are sold or given away as free samples. ISO 22715 was initially published in ...
Intelligent and smart packaging usually involve the ability to sense or measure an attribute of the product, the inner atmosphere of the package, or the shipping environment. This information can be communicated to users or can trigger active packaging functions. Programmable matter, smart materials, etc. can be employed in packages. Yam ...
The regulations have the force of California law [citation needed]. Some regulations, such as the California Department of Social Services Manual of Policies and Procedures concerning welfare in California, are separately published (i.e., "available for public use in the office of the welfare department of each county"). [1]
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
The dental dam is prepared by punching one or more holes in the dental dam sheet to enable isolation of the appropriate number of teeth required for the dental procedure. The dental dam is then applied to the tooth, anchored into place using a metal or flexible plastic clamp (chosen according to the tooth and area it will be applied to).