CAPA SJH OPEN
| No | SJH Audit | Description of Non Conformity | Category | Action Plan | Description | PIC | Due Date | Status | |
|---|---|---|---|---|---|---|---|---|---|
| CAPA/SJPH/MTU/2023/02 | I | Terdapat Primary PM yang tercantum dalam List Approved Supplier and Storage Condition for Packaging Material (MT-L-02/06) namun belum ada form kualifikasi vendor dan form pengajuan bahan baru : 1. ALFL BIOGESIC TAB 151 ex PT Avesta Continental Pack 2. ALFL BIOGESIC Tab 500 mg 104 SGP ex PT Avesta Continental Pack 3. ALFL BIOGESIC 500 mg 211 PHL ex PT Avesta Continental Pack dan Jiangyin 4, ALFL GDN PAIN RELIEF EXTRA CAP 106 SGP ex PT Indogravure 5. FF OBIMIN CALCIUM TAB 202 VNM ex PT Avesta Continental Pack 6. FF DECOLGEN PE 478 ex PT Avesta Continental Pack 7. FF ENZYPLEX CTAB 130 SGP MMR HKG ex PT Avesta Continental Pack 8. FF ENZYPLEX SCT 275 PHL ex PT Avesta Continental Pack 9. BF PLAIN 111 12 Mic ex PT Avesta Continental Pack 10. BF HORIZONTAL 111 12 MIC ex PT Indogravure 11. BF HORIZONTAL 206 12MIC ex PT Pura Barutama 12. PVC RIGID FILM 250 MIC 156 ex PT Uniflex Kemasindah 13. PVDC WHITE OPAQUE 102 120 GSM ex Liveo Research 14. PPC DOUBLE LAMI 28 MM ex PT Adhijaya Satmika Nusantara | CR | PA | 1. Revisi SOP Developing Alternate Supplier for PM (MT-SOP-24/xx) dan SOP Developing New PM (MT-SOP-30/xx) menambahkan ketentuan approval QA dalam pembuatan ASL PM seperti ASL RM untuk memastikan PM yang masuk ke ASL sudah melampirkan form kualifikasi vendor 2. Membuat file monitoring kualifikasi vendor | SEPTIAN ANGGADIBYA | 31 Jan 2024 | Open | Detail |
| CAPA/SJPH/MTU/2023/02 | I | Terdapat Primary PM yang tercantum dalam List Approved Supplier and Storage Condition for Packaging Material (MT-L-02/06) namun belum ada form kualifikasi vendor dan form pengajuan bahan baru : 1. ALFL BIOGESIC TAB 151 ex PT Avesta Continental Pack 2. ALFL BIOGESIC Tab 500 mg 104 SGP ex PT Avesta Continental Pack 3. ALFL BIOGESIC 500 mg 211 PHL ex PT Avesta Continental Pack dan Jiangyin 4, ALFL GDN PAIN RELIEF EXTRA CAP 106 SGP ex PT Indogravure 5. FF OBIMIN CALCIUM TAB 202 VNM ex PT Avesta Continental Pack 6. FF DECOLGEN PE 478 ex PT Avesta Continental Pack 7. FF ENZYPLEX CTAB 130 SGP MMR HKG ex PT Avesta Continental Pack 8. FF ENZYPLEX SCT 275 PHL ex PT Avesta Continental Pack 9. BF PLAIN 111 12 Mic ex PT Avesta Continental Pack 10. BF HORIZONTAL 111 12 MIC ex PT Indogravure 11. BF HORIZONTAL 206 12MIC ex PT Pura Barutama 12. PVC RIGID FILM 250 MIC 156 ex PT Uniflex Kemasindah 13. PVDC WHITE OPAQUE 102 120 GSM ex Liveo Research 14. PPC DOUBLE LAMI 28 MM ex PT Adhijaya Satmika Nusantara | CR | CA | 1. Membuat laporan kualifikasi vendor dan form pengajuan bahan baru untuk 14 PM diatas 2. Melakukan pengecekan dan melengkapi laporan kualifikasi vendor dan form pengajuan bahan baru untuk PM existing 3. Personel MTU Packdev melakukan training SOP Developing Alternate Supplier for PM (MT-SOP-24/xx) dan SOP Developing New PM (MT-SOP-30/xx) | SEPTIAN ANGGADIBYA | 31 Jan 2024 | Open | Detail |