Written information ought to be maintained so that facts can be employed for analyzing, at the very least per year, the quality benchmarks of every drug item to determine the necessity for modifications in drug products technical specs or production or Manage techniques.(b) Entire information shall be preserved of any modification of an established

Mencantumkan batas waktu pelaksanaan perbaikan dan PIC atau penanggungjawab untuk masing-masing tahap perbaikan.8D. A problem-solving methodology is intended to find a challenge's root trigger according to the ISO 9001 strategy.Dari analisa diatas diketahui bahwa “Why 4” sudah diluar wewenang pelaku usaha sehingga akar penyebab masalah adalah