Page 14 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com



                                              TRAINING OF PERSONNEL


                                              An effective training system requires that staff have
                                              a working knowledge of the principles of running a
                    KNOWLEDGE OF              QC laboratory. This also includes the understanding
                     QC PRINCIPLES
                                              of GMP as its applied to the laboratory (This forms
                                              the knowledge base for more technical training.


                                              All laboratory staff, including managers, supervisors,
                                              and analysis, should understand the intention and
                    UNDERSTANDING

                         OF SOPS              content of the SOPs that apply to them. They should
                                              be  able  to  follow  the  SOPs  and  interpret  them
                                              accurately.


                                              A fundamental requirement for laboratory analysis is

                                              to be able to accurately and repeatedly understand
                    INTERPRETATION            and  interpret  the  requirements  within  specific  test
                          OF TEST
                         METHODS              methods.      Test     methods      should     be     written
                                              unambiguously,  and  analysts  should  be  trained  in
                                              the application of each specific test method.


                                              The competency of analysts to execute test methods
                                              using  appropriate  analytical  techniques  is  on

                     APPLICATION OF           essential success factor for running a QC laboratory.
                       ANALYTICAL             Analysis  must  be  able  to  operate  complex
                       TECHNIQUES             instrumentation, prepare samples, and interpret the
                                              data.  And  calculate  the  results  without  error.  The
                                              application requires competency assessment.










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