Test Concept Document

Test Concept Document (TCD), which defines how to demonstrate that the solution acquired will meet the original user needs and, in particular, identifies critical issues that need to be resolved through the results of test and evaluation (T E). 

Keep records that document when and what was invented. It is important that accurate records are kept showing your original sketches with a disclosure statement describing what and how your invention works. It is useful to have someone witness this disclosure document and verify the date that this invention took place. It is often during this step that the invention concept is either modeled (mathematical or physical or both) and tested. Thus, accurate records of these analyzes or test results should also be kept. In the U.S. it is the first to invent that will obtain a patent in the event of two individuals inventing the same thing. Keep the disclosure document secret until the patent application is submitted to the patent office. 

There are three documents that give guidance on the design and conduct of in-use stability tests the EMEA/CVMP/127/95 final (adopted March 1996), CPMP/QWP/2570/98 (a concept paper adopted in November 1998) and CPMP/QWP/2934/99 draft (released for comment in December 1999). The studies undertaken may be discussed in the development pharmaceutics or the stability section of the dossier. 

In order to understand the use and intent of the various immunotoxicology regulatory guidelines and guidance documents, the difference between two concepts familiar to toxicologists should be emphasized. Hazard, identification refers to a method which is essentially qualitative that is, it is designed to detect the ability of a test article to produce a certain (in the context of toxicology) adverse effect, without reference to exposure issues. Risk assessment, on the other hand, takes into consideration method, dose, and duration of exposure, condition(s) of the exposed population, and concurrent... 

The concept of using accumulated final product as well as in-process numerical test data and batch records to provide documented evidence of product/ process validation was originally advanced by Meyers [26] and Simms [27] of Eli Lilly and Company in 1980. The concept is also recognized in the FDA s Guidelines on General Principles of Process Validation [1]. 

The complete master documentation file not only provides appropriate rationale for the product, process, and testing, but also becomes the reference source for all questions relating to the manufacture of a product at any plant location. This master documentation file, however, should not be confused with the concept of the master product document, which is essential for routine manufacturing of the product and is described later in the chapter. The master docu-... 

Jantunen M.J., et al. (2008) Final report for iF-project the intake fraction (iF) concept expansion and application tests. Report of Cehc-LRI contract B3.3-KTLE-0511 KTL - Department of Environmental Health, Kuopio. http //www.cefic-lri.org/uploads/ModuleXtender/ MCLibrary/1224664022/documents/iF hnal report.pdf. Cited 10 February 2009. 

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