Validation glossary

To provide the glossary of terms used in the SOPs with a particular reference to the validation and cGMP 

It is the responsibility of the validation team to understand and implement the terms defined in the validation lexicon. The QA manager is responsible for the SOP compliance. 

The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned, thus assuring that control parameters 

Demonstrating that a measuring device produces results within specified limits of those produced by a reference standard device over an appropriate range of measurements. This process results in corrections that may be applied if maximum accuracy is required. 

An element of quality assurance ensuring that all tests and measurements used to control and monitor the process or to test the product are capable of producing results that are accurate and precise to the extent dictated by importance of the measurement. 

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Preparation of standard procedures Document review Validation glossary Critical parameter assessment GMP criticality and risk analysis Process validation methodology Computerized system validation Preparation of validation plans Preparation of project and quality plans Manufacturing data specification... 

Note - This glossary is by no means exhaustive but it hopefully contains most of the more important terms you will come across in a typical NMR environment. Some of the entries may not even have featured in the text itself. Whilst every effort has been made to make the entries scientifically valid, please note that it is sometimes difficult to condense a highly complex topic into a pithy three-line explanation, so some of the definitions are sketchy to say the least ... 

Validation studies a glossary of some important terms... 

TABLE 2 Glossary for Method Validation According to ICH and Others... 

The glossaries in the 1990 and 2000 Washington conference final reports [1,3] define most of the analytical terms used in the validation of a method. However, internationally accepted definitions such as those by ISO or IUPAC already exist and have been elaborated carefully over many years [2,6]. The definitions reported in the 1990 and 2000 Washington conference final reports sometime agree only partially with the ISO and IUPAC. Following are some examples for comparison. 

To avoid confusion, the terms and parameters used in the validation of methods, for example, as used in Figure 3, must be clearly and unambiguously defined. This glossary contains the recommended definitions and corresponding descriptions and is based on the various standards and publications summarised in the Bibliography. This is not exhaustive and it is recommended that the lUPAC Orange Book be consulted if required. 

R.R.Herr and M.L.Wyrick, A Globally Harmonized Glossary of Terms for Communicating Computer Validation Key Practices, PDA Journal of Pharmaceutical Science and Technology, March/April 1999. 

An outline of how validation will be achieved and maintained A definition of who is to be responsible A glossary defining the terminology to be used... 

Figure 3.7 presents a set of life-cycle phases that summarize the validation approach typically used within the pharmaceutical and healthcare industries. Life-cycle phases may be known by alternative names in different organizations. There is no standard glossary throughout the industry relating to naming conventions or groupings of phases. It is important, however, that all the activities covered by this chapter are included in any alternative scheme. 

In addition, a Glossary may be added as required to aid understanding of the Validation Master Plan. Bear in mind that not all terms routinely used within the organization will be familiar to those outside it. 

Validation Report Glossary of Terms Document Index Navigation Aid Updated Training Records Support Procedures (System Management, Change Control, Disaster Recovery, Security Practice, Performance Monitoring, Periodic Review)... 

Herr Wyrick. A globally harmonized glossary of terms for communicating computer validation key practices. PDA J. Pharm. Sci. Technol. 1999, March/April. 

Finally, a number of Supplementary Chapters describe important topics such as endotoxin testing, statistical analysis of experimental results and guides for the nomenclature of complex natural or semi-synthetic drugs. Supplementary Chapter III F describes the validation of analytical procedures and contains a glossary of terms and their definitions, such as specificity, accuracy, precision, detection limit, etc. 

A Glossary of Bioanalytical Terms (Source Adapted from US Food and Drug Administration Guidance for Industry Bioanalytical Method Validation)... 

AN11 (glossary) prospective validation, AN5(2) pyrogens, AN1(52), AN1(69), AN12(14) qualification, glossary... 

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