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The distribution of medications has special drug safety and security considerations. [1] Some drugs require cold chain management in their distribution. [2] The industry uses track and trace technology, though the timings for implementation and the information required vary across different countries, with varying laws and standards. [citation ...
The Drug Industry Documents Archive (DIDA) is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management. DIDA is a part of the larger UCSF Industry Documents Library which includes the Truth Tobacco Industry Documents.
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 ...
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.
Industry records represent those records that are common and apply only to a specific industry or set of industries. Examples include but are not limited to medical industry records (e.g., the Health Insurance Portability and Accountability Act), pharmaceutical industry records, and food industry records.
The data surveyed by Reuters came from pharmaceutical regulators in Australia, Brazil, New Zealand and the United States; information from a commercial customs data provider for Kenya, Uzbekistan ...
IMS Health was an American company that provided information, services and technology for the healthcare industry.IMS stood for Intercontinental Medical Statistics. It was the largest vendor of U.S. physician prescribing data.
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]