Good laboratory practice validation

Good laboratory practice (validation) is required to assure accuracy of analyses. 

King, R.C. et al. 2002. Description and validation of a staggered parallel high performance liquid chromatography system for good laboratory practice level quantitative analysis by liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 16 43. 

Validation itself is considered a required part of good laboratory practice (GLP) and good manufacturing practice (GMP) within any pharmaceutical laboratory and has been defined by the FDA as ... 

You have your methodology both verified and validated as required for measurements needing a high level of confidence. But, you must also assure that your analyst Is experienced In performing the type of analysis you need, that you have standards for the analytes available, and that you have a written quality assurance plan that documents good laboratory practice. 

Good Laboratory Practice (GLP) The system provides a comprehensive feature set to aid customers in meeting GLP requirements. This includes features such as certificate-of-software validation, user-access levels, instrument and sequence logbooks, system-suitability software for aU supported HP instruments, standard GLP reports, and a GLP save option that encrypts and saves data and methods together. 

In the pharmaceutical industry, it is important that aU products are properly tested and vahdated prior to release for sale. One of the most important tests is the determination of tablet dissolution rate. In this procedure tablets are immersed in a suitable medium to mimic the action of the stomach and the release of the active ingredients monitored over a period of time. Automation of these procedures is obviously important for various reasons including cost, accuracy of analysis and for validation of the results according to good laboratory practice. 

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

In summary, when using the indirect" technique for optical trace analysis, all of the points mentioned above have to be considered and have to be validated when setting up a standard operation procedure" (SOP), in order to conform to good laboratory practice (GLP) analysis methods. This means an extra work load compared with validation of the direct optical trace analysis procedure. Sometimes there is no way of getting round this so-called less elegant , more cumbersome and more error prone indirect technique. However, if it is performed correctly and judged critically, it is still a good method and should easily allow optical trace analysis down to 0.1% and lower. 

All the discovery stage quantitative and qualitative LC-MS assays (levels I, II, and III), which are used to select dmg candidates for development, are not rigorously validated and are not required to satisfy any of the good laboratory practices (GLPs) guidelines set forth by the regulatory agencies (Shah et al., 2000 Hsieh and Korfmacher, 2006 Jemal and Xia, 2006). 

Emerging fran this exercise was the development of official NACA position papers on "The Reliability of Test Data in Pesticide Research" and "Good Laboratory Practices" in 1979. Needless to say, the policy on the former indicated that the industry supported the concept of reliable test data in pesticide research. The issue was hew does one determine reliability or validity. The industry addressed the question this way ... 

GOOD LABORATORY PRACTICE REGULATIONS RELATED TO COMPUTER SYSTEMS VALIDATION... 

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