Validation summary

The quantitation of phospholipids by means of NMR spectroscopy is a valid method. Method precision (reproducibility) and instrument precision show for the main component a standard deviation 1% components near the limit of quantitation have a standard deviation below 5%. In terms of the liposome lyophilisate preparation used the extraction recovery of the phospholipids was 100%. 

The analysis method is robust. It is almost insensitive to variation in sample preparation and measurement parameters. Prepared samples can be stored up to 5 days at room temperature (a typical storage time in practical experimental applications would be 24 h) before measurement without negative influence on the results. Manual integration is the preferred method and control of integration limits is recommended if automatic integration is to be used. 

All NMR spectra were measured at Spectral Service GmbH, Cologne, Germany, on an NMR Spectrometer AC-P 300 (Bruker, Karlsruhe, Germany) equipped with automated sample changer and QNP-head for nuclei H, and P. Magnetic flux density is 7.05 T proton 

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Even if the hazard ratio is not precisely a constant value as we move through time, the hazard ratio can still provide a valid summary provided the hazard rate for one of the treatment groups is always above the hazard rate for the other group. In this case the value we get for the hazard ratio from the data represents an average of that ratio over time. 

The method for sterility testing of (product name) USP is manufacturing site SOP and the microbiological sterility method validation summary report is provided in (provide reference attachment number). The USP bacteriostasis/fungistasis test was performed to validate the sterility test method... 

Sterility testing of (specify name) USP microbiological sterility method validation summary report... 

As stated earlier, the conclusions capture the overall results of the activity. The conclusions section should be concise. This section is lifted from the body of validation summary and copied onto the cover page. 

Validation Summary Report (VSR) Documents confirming that the entire project planned activities have been completed. On acceptance of the Validation Summary Report, the user releases the system for use, possibly with a requirement that continuing monitoring should take place for a certain time (GAMP). 

In order to determine whether all VMP requirements have been met, the CRS VMP should require what will be referred to as a master validation summary report (MVS). The MVS should discuss each deliverable required by the... 

In this guidance the FDA offers some direction for the demonstration of comparability. They request that the manufacturer provide evidence that the methods, facilities, and controls that were used to manufacture previous products conformed to cGMPs and to other applicable regulatory requirements. In addition they request the submission of validation summaries, as well as product characteristics such as total nucleated cell count, viable CD34 cell count, and number of colony-forming units. Stability data and information from the scientific literature can also be used. Clinical outcomes can be part of the comparability demonstration. 

The BLA should include information for systems used in the production of water for manufacturing and rinsing of product-contact equipment. This subsection should include a general description of water system(s), a validation summary, and information on the routine monitoring program. 

This subsection must also include a general system description, a validation summary, and information on the routine monitoring system. 

This section should contain information on computer systems that control critical manufacturing processes. The developer of the system should be identified and information provided also should include a brief description of procedures for changes to the computer system. This section also should contain a validation summary for each of these systems and a certification that an IQ and OQ have been completed. 

During regulatory inspections, the Validation Plan can be presented with a Validation Report or Validation Summary Report to demonstrate that a particular computer system has been validated. These documents provide a regulator with additional detail to the Validation Determination document and Validation Certificate but without digressing into the supporting validation evidence. 

Installation Qualification Operational Qualification Performance Qualification Operation and Maintenance Prerequisites Validation (Summary) Report... 

Some pharmaceutical and healthcare companies prepare what is referred to as a Validation Summary Report. This is really the Validation Report described above, but at a very high level with little detail. 

The concept of a Validation Summary Report can be taken a step further in the form of a Validation Certificate. This merely states that a computer system is validated, and it specifies a review date against this validated status. While a Validation Certificate could be presented to a regulatory inspector as evidence of validation, this would probably just prompt the inspector to request more detailed information. The effort to produce and maintain Validation Certificates must be carefully weighed. 

Prerequisites Validation (Summary) Report X X X X Backup and Restoration, Security, Training, Business Continuity Plans Response to Validation (Master) Plan including Statement... 

It is sometimes neeessary to modify the oiigiaal intent of a eomputer system or validation strategy to some degree in order to aehieve an aeeeptable outeome. The Vahdation Snmmary Report should highhght and justify sueh ehanges of direetion. As for Vahdation Reports, Validation Summary Reports should be made available to the FDA in Fmghsh. 

The validation summary report brings together all of the documentation collected throughont the whole of the life cycle and presents a recommendation for management approval when the system is validated. The emphasis is on using a summary report as a rapid and efficient means of presenring results as the detail is contained in the other documentation in the validation package (see Chapter 11 for more details). 

The Validation Summary Report (VSR) concludes the validation activities, detailing the deliverables and identifying any deviations from the Validation Plan. At this point a release notice can be issued and the project closed with activities such as document indexing and storage. 

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