Page 53 - Q&A Implementasi Pedoman CPOB 2018
P. 53

Persyaratan metode analisis tertentu (NIR) dapat merujuk
                   referensi:
                     Guideline on The Use of Near Infrared Spectroscopy by
                      The   Pharmaceutical   Industry   and   The   Data
                      Requirements For New Submissions and Variations No.
                      EMEA/CHMP/CVMP/QWP/17760/2009 Rev2, 27 January
                      2014
                     Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev
                      2:  Defining  the  Scope  of  an  NIRS  Procedure  No.
                      EMA/CHMP/CVMP/QWP/63699/2014, 5 June 2014.





































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