Development of the System for Validation of Testing Methods

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Ekalak Songtan
Kanitta Phuwanartnaranubarn
Puntawit Natakul


          The Institute of Biological Products (IBP) has developed a guideline for method validation of testing methods which is imposed systemic direction into quality system creating codes, format, protocol of planning and report of method validation of testing. Therefore, there is the same operation that can control pre-and post-steps of method validation of testing, and it can also be the standard for traceability. As a result, the IBP has good standard operating procedures implemented for method validation of testing. The system has been developed for 14 years, thus the IBP has academic evidences that can prevent errors of testing with inappropriate methods for decision making of product quality that the disqualified products will not be released. The system will support the communication of the IBP which is the National Control Laboratory for controlling biological products and stakeholders, such as manufacturer and importer to understand correctly for all topics. Also, it can be useful for communication between auditors and auditees in laboratory competency assessment.


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