Release document

Those parts of this research that involve cellular automata are described in chapter 11 of this book. For additional details, including all approved-for-public-release documentation, see... 

Deployment It is in this phase that the business or domain makes its transition to the to-be model, adopting new processes, hardware, and software. It involves things such as software and hardware installation, tools to upgrade or migrate to new releases, documentation, acceptance testing, and user and administrator training. Note that user docu-... 

For semisolid products, any change in the preservative may affect the quality of the product. If any quantitative or qualitative changes are made in the formulation, additional testing should be performed. No in vitro release documentation or in vivo bioequivalence documentation is needed for preservative changes. 

II. In Vitro Release Documentation. The in vitro release rate of a lot of the dosage form prepared in new equipment should be compared with the re-... 

II. In Vitro Release Documentation. The in vitro release rate of a lot of the dosage form prepared by the new/modified process should be compared with the in vitro release rate of a recent lot of comparable age of the dosage form prepared by the prechange process. The median in vitro release rates (as estimated by the estimated slope from each cell, see VII) of the lots prepared by the two processes should be demonstrated to be within acceptable limits, using the testing procedure described in section VII (IN VITRO RELEASE TEST) below. 

In vitro release rate of new/modi-fied formulation established as point of reference. In vitro release documentation not required, but this information should be developed for use in subsequent changes. 

In vitro release documentation None None In vitro release rate compared to recent lot of comparable age prechange scale of product. Median in vitro release rates 1 of the two formulations should be within acceptable limits. in vitro release rates... 

The identity of custodians of controlled copies of documents should be defined in the Validation Plan, the Project and Quality Plan, or the document management procedure. The allocation of released documents to these individuals should be controlled through managed distribution lists. Superseded versions of controlled documents must be replaced in a eomprehensive and timely fashion. Obsolete versions of documents must be clearly marked as superseded. 

Standard Release Documentation The specification and testing documentation is shared among many installations so its unit cost per apphcation should be less than that for bespoke software. 

The relationship between user validation and development of the standard application must be clearly understood and described in an application s Validation Plan. Users should review and accept standardized application release documentation. Supphed documentation must match the version of the standard software being implemented. Table 14.2 suggests the general spht in documentation between a user validation and standardized application document. 

Upgrade Versions Caution is needed when implementing new versions or bug fixes to standardized apphcations. Release documentation should coufirm coutiuued quality of software. If serious doubts exist over software quality, commouseuse should prevail aud the software should be treated as customized or eutirely bespoke, aud heuce require full validation. 

The US Environmental Protection Agency s Toxics Release Inventory Program of reported releases documented a total release of 24.5 X lO pounds (11 x 10 kg) of Al fume or dust in 2000 (US EPA 2002a). Considerable effort has been devoted toivard Al recovery from ivaste generated by its production and from coal-fired poiver stations. Bioleaching Al from industrial ivaste by microorganisms has also been demonstrated (Bojinova and Velkova 2001). 

A finished product can be shipped out only on the basis of the results of inspections confirming its satisfactory quality. The release documentation of a finished product contains an evaluation of the production conditions, the results of routine production checks, verification of the production documentation, the results of between-operafion and exit checks, and appraisal of the finished end package. 

The release documents issued for starting materials must not be older than five years. For the production of parenteral medicines, the release documents may not be older than two years. After this time expires, after retesting it is possible to issue a new protocol (certificate), if all inspection tests reveal satisfactory quality. The useabiirty of the starting substances on the basis of the new protocol (certificate) must be limited in time. 

Marwick C (2003) Bayer is forced to release documents over withdrawal of cerivastatin. BMJ 326 518... 

This release documentation, forms a basis for the production of the components, systems or vehicles, and is signed by the person... 

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