Specification validation

These are commercially available operating systems (e.g. Microsoft Windows XP). They are not subject to specific validation, but features are functionally evaluated and challenged during testing of the application... 

In summary, the procedure of the Nordic Committee describes a comprehensive validation protocol, but it is not specially designed for pesticide residue analysis and has no preferences with regard to single- or inter-laboratory validation. Therefore, if it is applied to pesticide residue methods, some specific validation requirements should be added. The procedure clearly lists all necessary steps of validation and adjusts its recommendations to the degree of previous external validation. 

Validation protocol Document describing the specific item to be validated, the specific validation protocol to be carried out and acceptable results, as per acceptance criteria... 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

For a method to be considered as part of commercial specification, validation using ICH guidelines (Q2A and Q2B) is required (see also Chapters 9 and 10). Depending on method characteristics, different validation schemes may be used. The following parameters should be considered to ensure the method is valid and appropriate for its intended purpose accuracy, precision (repeatability, intermediate precision), specificity, limit of detection (LOD), limit of quantification (LOQ), linearity, and range. 

WHO hosts The International Pharmacopoeia. This pharmacopoeia is based on specifications validated internationally, through an independent international scientific process. 

Thus, there is a long and successful history of using pharmacological effects to validate psychiatric diagnosis. Examination of the individual areas of diagnosis demonstrates these specific validation efforts. 

Table 5 summarizes the comparison of the vahdation requirements with the verification requirements of the HPLC assay of an example final dosage form. ICH requires the validation of accuracy, precision, specificity, linearity, and range. Generally, verification will only require a minimal of precision and specificity validation. The accuracy requirements will be dependent on the specific situation of the final dosage form. 

Vessman, J. (1996), Selectivity or specificity Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry, J. Pharm. Biomed. Anal, 14,867-869. 

The guidelines contained within this chapter should be considered as part of a comprehensive validation program for solid oral dosage forms. The unique formulation or process characteristics of a particular product and the equipment available to manufacture that product may dictate the need for a specialized validation program. As such, the multidisciplinary validation team must identify the product and process characteristics that must be studied and incorporate specific validation tests to ensure that that product will meet all quality, manufacturing, and regulatory requirements. 

Of course these pieces or steps begin in development with initial process-development activities and conclude with product commercialization. All pre-process validation activities—from the initial ranging studies to the process-specific validations—can be dubbed as PQ activities, since they create a certain level of comfort with the process. These activities typically involve more than three full-scale runs—the number usually associated with validation. How exactly does this work How can a qualification require more runs than a validation The answer is very simple validation includes qualification, which means... 

A project- or system-specific validation plan should address the following in sufficient detail to form the basis for reporting the validation program ... 

Train and qualify operational and supervisory laboratory and plant personnel in product-specific validation principles. 

Emphasis is placed on preparing a validation protocol in which the specific validation experiments and associated acceptance criteria substantiate that the method meets its technical and regulatory objectives. Only after these steps does the process conclude with the performance of the formal validation and generation of the validation report. Finalization of method development (by way of the method validation) is never truly complete, as validation is aliving process that encompasses the ongoing use of the method in various laboratory settings. 

Regulatory submissions Specifications Validated systems Training... 

STDs in matrix may be prepared ahead of the time and stored as long as analytes stability in matrix has been demonstrated. STD and QC pools are prepared according to the specific validated analytical methods. Spiked solutions cannot be used beyond the established stability. After qualification, the standard and QC pools should be prealiquoted out and stored under designated condition and temperature. 

Nonideally, physicists are still wrestling with real conductors as opposed to infinite-s ideal metals. The real problem is the n = 0 term in the summation for the van der Waals free energy. Its character differs from those at finite frequency and must therefore be trusted only in specifically validated cases. For real conductors, properties of the form —e2/ o)(o)me + iy)] are expressed explicitly in terms of conductivity a as a term... 

New disease-specific, validated targets are needed. We have mentioned before that oncology is rich in targets. This is neither an accident nor a surprise. It is rich in targets because there is so much basic research. An estimated 10.7 billion is being spent annually on basic research by the National Cancer Institute (NCI) ( 5.5 billion). Big Pharma ( 4.0 billion), and Biotech ( 1.2 billion). Oncology is probably the only area of research where Pharma does not outspend the public. 

For analytical method validation during full development (after final synthesis has been set for drug substance and after final market formulation has been set for drug product) corresponding to the definitive control procedure for new drug application (NDA), a specific validation protocol has to be written. Before start of the experimental work, the protocols must be written... 

Software tools supporting the functionality of applications should also be validated. Specific validation is not required because validation is inferred by validating the correct operation of the application itself. Examples include operating systems (GAMP Category 1 Software) that should be validated as GAMP Category 1 software. 

Note There are no specific validation activities for Category 1 software (COTS compilers and operating systems) beyond documenting version details. 

Formally agreed and documented sponsor requirements Formally documented design specifications Validation planning for sponsor-specific project Snpplier anditing... 

Optical images may be produced by scanning in a paper document or a faxed image into the system. Apart from general configuration and installation requirements, specific validation considerations should include ... 

Regulatory authorities do not generally inspect these systems instead they inspect individual training records. Such systems should, however, be validated to ensure their reliability and performance. Specific validation issues to be addressed include "... 

The repository may range from a specific directory on a server, with a work group password protection, to a software package-controlled database repository implementing full database security controls. There may also be a requirement to produce and store multiple renditions of a document within the repository. Specific validation issues include ... 

Educates supplier in customer-specific validation requirements... 

Maintenance procedures and work instructions Engineering drawings Design and construction specifications Validation documentation... 

It is generally not practical to maintain a complete set of system documents at each site that is supported by an MRP II system (remember, there may be many thousands of documents). A complete set of documents should be managed at a central location, with key stage and site-specific validation documents being formally copied to sites. 

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