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In January 2009, FDA issued a new cGTP draft guidance for industry entitled "Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)".
On Monday, the U.S. Food and Drug Administration (FDA) announced that, ... Guidance for Industry," it added, is the latest move to support its Closer to Zero initiative, which aims to "reduce ...
In 2008 the FDA released the Guidance for Industry: Indexing Structured Product Labeling [4] which started the FDA's product information indexing initiative with the goal of enhancing access to the electronic product information provided by the companies. Indexing refers to the creation by FDA of one or more SPL files with machine-readable ...
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.
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 ...
The guidance titled "Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry" is part of the FDA's Closer to Zero initiative to reduce exposure to ...
Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance. BROKEN LINK; Troetel, W.M.: Achieving a Successful US IND Filing (1) The Regulatory Affairs Journal. 6: 22–28, January 1995.
The FDA has outlined a regulatory framework [1] for PAT implementation. With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the ...