• Thai Industrial Pharmacist Association Conference 

    Date Posted : 20 Nov 2019

    Event Date  :   12 Nov 2019 - 13 Nov 2019
    Event Venue  :   @Ambrassdor Hotel Bangkok

    TIPA 2019 ANALYTICAL METHOD VALIDATION FOR FDA CONPLIANCES, To use drug product quality assurance Quality control of pharmaceutical raw materials and products requires reliable analysis and testing methods. Providing accurate and accurate test analysis results Therefore, the aforementioned method of test analysis is necessary to conduct a validation check called Analytical Method Validation and because of the test items including the analysis methods in those topics, there are chemical and biological tests such as Assay, Dissolution, Impurities and analysis Organic and Inorganic impurities, including residual solvents. Therefore, understanding the principles As well as considering the topics that need to be checked for accuracy Therefore it is necessary From the formula development process Quality control during production and finished products Process validation validation, cleaning validation, and stability studies And because at present USP has improved quality control for heavy metals. metals) to be Elemental impurities according to General Chapter Elemental. impurities-Limits and Elemental impurities-Procedures for such tests also need to be checked for accuracy. In addition, if analytical methods are being developed and validated from a laboratory (Transferring unit) by another laboratory (Receiving unit) For example, the laboratories of the Quality Control Department will use methods developed from research and development laboratories. It is necessary to have a process that ensures that Receiving The unit will be able to carry out the tests correctly. Providing reliable test results In which the process is method Transfer, which is also one of the processes identified in the General Chapter of the USP (Transfer of Analytical Procedures) Therefore, in order to make the operation of the analysis and testing of the laboratory Providing reliable analysis results Including those involved, therefore it is necessary to conduct studies in order to understand As well as being able to comply with the requirements of the pharmaceutical product regulatory authorities

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