Dokumen Administrasi :1. Agar nama

Dokumen Administrasi :
1. Agar nama produk Pro Liver diganti karena promotif. 2. Agar surat penunjukan mencantumkan identitas jelas pemberi kuasa (nama, jabatan, dan tanggal) 3. Lampirkan GMP yang dikeluarkan oleh ministri of health and welfare ROC Taiwan)
• Dokumen Mutu :
1. Lampirkan batch record production dan IPCQ 2. Bahan baku: -Agar disebutkan referensi yang digunakan dalam penetapan spesifikasi bahan baku -Lampirkan kromatogram sesuai hasil identifikasi pada masing-masing bahan baku -Lampirkan metode pemeriksaan kadar dari marker bahan baku seperti Ferulic acid, synephrine, verbascoside. 3. Agar dilakukan pengujian ulang kadar air dari lab terakreditasi di Indonesia yang sama dengan pengujian 1 dan produk dengan bets yang sama pula 4. Uji stabilitas: -Agar dilampirkan kromatogram proses identifikasi pada pengujian stabilitas -Agar dilampirkan protocol uji stabilitas dan kondisi penyimpanan selama uji stabilitas -Agar dijelaskan senyawa PNS yang diperiksa kadarnya pada uji stabilitas (“PNS content should be 80-120%) -Lampirkan kesimpulan hasil ujis tabilitas yang ditandatangani oleh penanggungjawab mutu. 5. CoA produk jadi dari produsen -Lampirkan hasil pengujian produk jadi dari produsen yang memuat spesifikasi dan referensi yang digunakan dalam pemeriksaan mutu produk 6. Lampirkan formulis TD yang mencakup khasiat produk, cara pemakaian dan peringatan-peringatan jika ada.

結果 (英文) 1:

Administrative Documents:1. In order that the product name was changed because the Liver promotif Pro. 2. In order for the letter designation includes the power givers clearly identity (name, title, and date) 3. Attach a GMP ministri of issued by health and welfare ROC Taiwan) • Document The Quality:1. Attach the batch production record and IPCQ 2. Raw materials:-in order for the mentioned references used in the setting of raw material specifications-attach kromatogram according the results of identification on each raw material-attach method checks the levels of the marker raw materials such as Ferulic acid, synephrine, verbascoside. 3. In order to be done re testing moisture content of an accredited lab in Indonesia which is equal to 1 and testing products with the same batch of 4. Test stability:-in order to be attached kromatogram identification process on stability testing-test protocol attached in order for stability and storage conditions for stability-in order to test the compound described the PNS review simply applied on the test stability ("PNS content should be 80-120%)-attach the conclusion results ujis tabilitas signed by a responsible quality. 5. CoA finished product from the manufacturer-attach the test results to the manufacturer of a finished product containing the specifications and references that are used in product quality inspection 6. Attach formulis TD that covers the benefits of the product, how to use and warnings if any.