Listing Document PT. Indofarma Tbk
Bidang : Quality Assurance
| Kelompok | No. Dok. | Revisi | Nama Dokumen | Tgl. Berlaku | Tinjauan 1 | Tinjauan 2 | Status |
|---|---|---|---|---|---|---|---|
| Sertifikat | ID03/00102 | 00 | Sertifikat ISO 9001;2015 Issue 10 | 31-05-2021 | Berlaku | ||
| Sertifikat | 912000721297100030002 | 00 | Sertifikat CPAKB Peralatan Kimia Klinik dan Toksikologi Klinik | 26-09-2023 | Berlaku | ||
| Site Master File | DIIF | 01 | Daftar Induk Industri Farmasi | 27-07-2022 | Berlaku | ||
| Daftar | DKK001 | 00 | Daftar Petugas Kalibrasi | 26-07-2017 | Berlaku | ||
| Daftar | DKVK01 | 02 | Tempat dan Waktu Kalibrasi | 02-01-2022 | Berlaku | ||
| Daftar | DKVK02 | 02 | Laboratorium Kalibrasi Eksternal | 29-04-2021 | Berlaku | ||
| Daftar | DKVQ01 | 00 | Akses Level Otoklaf Pharmalab | 01-10-2018 | Berlaku | ||
| Daftar | DKVQ02 | 00 | Daftar Parameter Kritis Kualifikasi | 15-10-2018 | Berlaku | ||
| Daftar | DKVQ03 | 01 | Daftar Cakupan Air Handling Unit (AHU) | 28-01-2019 | Berlaku | ||
| Daftar | DKVQ04 | 01 | Kategori Mesin | 27-12-2019 | Berlaku | ||
| Daftar | DPE002 | 17 | Penyimpanan Produk Farma PT.Indofarma | 04-08-2023 | Berlaku | ||
| Daftar | DPE003 | 00 | Penyimpanan Alat Diagnostik di Logistik Produk Jadi | 01-08-2012 | Berlaku | ||
| Daftar | DPE004 | 02 | Daftar Produk Sangat Sensitif | 08-12-2017 | Berlaku | ||
| Daftar | DPE005 | 02 | Daftar Produk Sensitif | 08-12-2017 | Berlaku | ||
| Daftar | DPE006 | 02 | Daftar Produk Stabil | 08-12-2017 | Berlaku | ||
| Daftar | DPE007 | 00 | Parameter Kritis | 10-07-2015 | Berlaku | ||
| Daftar | DPE008 | 01 | Produk Psikotropika, Prekursor dan OOT PT. Indofarma | 09-11-2018 | Berlaku | ||
| Daftar | DPE009 | 01 | Daftar Parameter Pengujian dan Kriteria Penerimaan Sampel Stabilitas On Going | 05-11-2018 | Berlaku | ||
| Daftar | DPE010 | 01 | Daftar Jumlah Sampel Stabilitas On Going | 05-11-2018 | Berlaku | ||
| Daftar | DPE011 | 00 | Referensi Studi Literatur Ilmiah dan Laporan dari Badan Otoritas Negara Lain | 31-07-2019 | Berlaku | ||
| Daftar | DPE012 | 00 | Penyimpanan Produk Obat Tradisional dan Suplemen Kesehatan (OTSK) PT. Indofarma | 04-08-2023 | Berlaku | ||
| Daftar | DPE013 | 00 | Penyimpanan Alat Kesehatan dan Perbekalan Alat Rumah Tanggan PT. Indofarma | 04-08-2023 | Berlaku | ||
| Daftar | DQS001 | 00 | Daftar Key Performance Indicator ISO 9001:2015 | 28-12-2020 | Berlaku | ||
| Daftar | DQS002 | 01 | Daftar Risiko Mutu Bidang Pengawasan Mutu | 28-04-2020 | Berlaku | ||
| Daftar | DQS003 | 00 | Materi Pelatihan Sistem Mutu | 18-05-2020 | Berlaku | ||
| Daftar | DQS005 | 00 | Daftar Risiko Mutu Bidang Pemastian Mutu | 05-06-2020 | Berlaku | ||
| Sertifikat | E-MCBSSH066-IDN | 00 | Sertifikat Sistem HACCP | 11-05-2021 | Berlaku | ||
| Formulir | F-PM-01-07 | 00 | Catatan Hasil Kalibrasi Internal Friability Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-08 | 00 | Catatan Hasil Kalibrasi Internal Karl Fisher Titrator | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-09 | 00 | Catatan Hasil Kalibrasi Internal Automatic Titrator | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-10 | 00 | Catatan Hasil Kalibrasi Internal Stopwatch | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-11 | 00 | Catatan Hasil Kalibrasi Internal Antibiotic Zone Reader | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-12 | 00 | Catatan Hasil Kalibrasi Internal Disintegration Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-13 | 00 | Catatan Hasil Kalibrasi Internal Autoclave | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-14 | 00 | Catatan Hasil Kalibrasi Internal Analing Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-15 | 00 | Catatan Hasil Kalibrasi Internal Hardness Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-16 | 00 | Catatan Hasil Kalibrasi Internal HPLC Hitachi | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-17 | 00 | Catatan Hasil Kalibrasi Internal HPLC Waters | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-18 | 00 | Catatan Hasil Kalibrasi Internal Thermometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-18a | 00 | Catatan Hasil Kalibrasi Internal Thermometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-19 | 00 | Catatan Hasil Kalibrasi Internal Conductivitymeter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-20 | 00 | Catatan Hasil Kalibrasi Internal Refractometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-21 | 00 | Catatan Hasil Kalibrasi Internal Fluorescence Spectrophotometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-22 | 00 | Catatan Hasil Kalibrasi Internal Particle Counter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-24 | 00 | Catatan Hasil Kalibrasi Internal Refrigerator | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-25 | 00 | Catatan Hasil Kalibrasi Internal Bonding Strength dan Sealing Strenght Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-26 | 00 | Catatan Hasil Kalibrasi Internal Gelas Ukur | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-27 | 00 | Catatan Hasil Kalibrasi Internal Flame Photometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-28 | 00 | Catatan Hasil Kalibrasi Internal Melting Point Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-29 | 00 | Catatan Hasil Kalibrasi Internal Rotavapor | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-31 | 00 | Catatan Hasil Kalibrasi Internal Dissolution Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-31a | 00 | Catatan Hasil Kalibrasi Internal Dissolution Tester | 04-09-2014 | Berlaku | ||
| Formulir | F-PM-01-32 | 00 | Catatan Hasil Kalibrasi Internal Viscosity Meter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-33 | 00 | Catatan Hasil Kalibrasi Internal Piknometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-34 | 00 | Catatan Hasil Kalibrasi Internal Granulate Flow Tester | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-35 | 00 | Catatan Hasil Kalibrasi Internal Climatic Chamber | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-36 | 00 | Catatan Hasil Kalibrasi Internal Air Sampler | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-37 | 00 | Catatan Hasil Kalibrasi Internal Micro Pipette | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-38 | 00 | Catatan Hasil Kalibrasi Internal Spuit/Syringe | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-39 | 00 | Catatan Hasil Kalibrasi Internal Thermohygrometer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-40 | 01 | Catatan Hasil Kalibrasi Internal Timbangan | 08-08-2018 | Berlaku | ||
| Formulir | F-PM-01-41 | 00 | Catatan Hasil Kalibrasi Internal Timer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-43 | 00 | Catatan Hasil Kalibrasi Internal Thermocouple Of Vessel | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-44 | 00 | Catatan Hasil Kalibrasi Internal Thermocouple | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-45 | 00 | Catatan Hasil Kalibrasi Internal RPM Rotary Regulator | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-46 | 01 | Catatan Hasil Kalibrasi Internal Polari Meter | 08-08-2018 | Berlaku | ||
| Formulir | F-PM-01-47 | 00 | Catatan Hasil Kalibrasi Internal Temperature Indicator | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-48a | 03 | Catatan Hasil Kalibrasi Internal Magnehelic (Diff. Pressure) | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-49 | 00 | Catatan Hasil Kalibrasi Internal Moisture Analyzer Balance | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-50 | 00 | Catatan Hasil Kalibrasi Internal Buret | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-51 | 00 | Catatan Hasil Kalibrasi Internal pH Meter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-51a | 01 | Catatan Hasil Kalibrasi Internal pH Meter | 01-03-2017 | Berlaku | ||
| Formulir | F-PM-01-53 | 00 | Catatan Hasil Kalibrasi Internal Pipet Bersekala | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-54 | 00 | Catatan Hasil Kalibrasi Internal Labu Ukur | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-55 | 00 | Catatan Hasil Kalibrasi Internal HPLC Shimadzu | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-57 | 00 | Catatan Hasil Kalibrasi Internal HPLC Waters Millenium | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-58 | 00 | Catatan Hasil Kalibrasi Internal Anak Timbangan | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-59 | 00 | Catatan Hasil Kalibrasi Internal FTIR Bruker ALPHA | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-60 | 00 | Catatan Hasil Kalibrasi Internal RPM Thumbler | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-61 | 00 | Catatan Hasil Kalibrasi Internal Counter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-63 | 00 | Catatan Hasil Kalibrasi Internal Granulate Flow Terster | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-64 | 00 | Catatan Hasil Kalibrasi Internal Tapped Volumeter | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-65 | 00 | Catatan Hasil Kalibrasi Internal Timbangan | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-65a | 00 | Catatan Hasil Kalibrasi Internal Timbangan | 04-09-2014 | Berlaku | ||
| Formulir | F-PM-01-67 | 00 | Catatan Hasil Kalibrasi Internal Spectrofotometer Perkin Elmer | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-70 | 00 | Catatan Hasil Kalibrasi Internal Autoclave Thermocouple | 03-09-2014 | Berlaku | ||
| Formulir | F-PM-01-72 | 00 | Catatan Hasil Kalibrasi Internal Low Pressure | 01-06-2015 | Berlaku | ||
| Formulir | F-PM-01-73 | 00 | Catatan Hasil Kalibrasi Internal High Pressure | 01-06-2015 | Berlaku | ||
| Formulir | F-PM-01-76 | 00 | Catatan Hasil Kalibrasi Internal Spectrofotometer Hitachi UM5300 | 08-08-2018 | Berlaku | ||
| Formulir | F-PM-01-78 | 00 | Catatan Hasil Kalibrasi Eksternal | 01-11-2018 | Berlaku | ||
| Formulir | FKV001 | 01 | Permintaan Mengikuti Proses Untuk Validasi | 29-04-2014 | Berlaku | ||
| Formulir | FKV002 | 03 | Catatan Hasil Verifikasi Timbangan | 03-10-2018 | Berlaku | ||
| Formulir | FKV003 | 00 | Pengukuran Kualifikasi Jabatan Pelaksana Kalibrasi | 23-01-2015 | Berlaku | ||
| Formulir | FKV005 | 00 | Seleksi Laboratorium Kalibrasi Eksternal | 30-08-2017 | Berlaku | ||
| Formulir | FKV006 | 00 | Evaluasi Laboratorium Kalibrasi Eksternal | 30-08-2017 | Berlaku | ||
| Formulir | FKV007 | 00 | Pemakaian Alat Kalibrator | 13-02-2018 | Berlaku | ||
| Formulir | FKV008 | 01 | Pemantauan HEPA Filter Laminar Air Flow | 30-01-2020 | Berlaku | ||
| Formulir | FKV009 | 00 | Verifikasi Pemasangan Magnehelic Setelah Dikalibrasi | 02-12-2019 | Berlaku | ||
| Formulir | FKV010 | 00 | Pengajuan Kalibrasi / Kualifikasi untuk Ruangan / Mesin / Peralatan / Instrumen | 11-05-2022 | Berlaku | ||
| Formulir | FPE008 | 01 | Catatan Harian Pemantauan Retained Sample Produk Non Close Monitoring | 31-08-2018 | Berlaku | ||
| Formulir | FPE009 | 01 | Catatan Harian Pemantauan Retained Sample Produk Close Monitoring | 31-08-2018 | Berlaku | ||
| Formulir | FPE010 | 01 | Data Mock Recall Logistik Produk Jadi INF | 14-08-2018 | Berlaku | ||
| Formulir | FPE011 | 01 | Data Mock Recall IGM Pusat | 14-08-2018 | Berlaku | ||
| Formulir | FPE012 | 01 | Data Mock Recall IGM Cabang | 14-08-2018 | Berlaku | ||
| Formulir | FPE013 | 01 | Rekonsiliasi SCM PT.INF / PT.IGM | 14-08-2018 | Berlaku | ||
| Formulir | FPE014 | 02 | Pemusnahan Retained Sample Non Psikotropika, Prekursor, OOT | 08-03-2022 | Berlaku | ||
| Formulir | FPE016 | 01 | Jadwal Pemantauan Stabilitas On Going Produk Komersial | 31-08-2018 | Berlaku | ||
| Formulir | FPE017 | 00 | Protokol dan Laporan Stabilitas On Going Produk Komersial | 12-07-2018 | Berlaku | ||
| Formulir | FPE018 | 00 | Laporan Hasil Analisis Stabilitas On Going | 12-07-2018 | Berlaku | ||
| Formulir | FPE019 | 00 | Pemeriksaan Awal Retained Sample | 08-11-2018 | Berlaku | ||
| Formulir | FPE020 | 00 | Catatan Retained Sample | 08-11-2018 | Berlaku | ||
| Formulir | FPE021 | 02 | Catatan Sanitasi Ruang Retained Sample | 12-09-2022 | Berlaku | ||
| Formulir | FPE022 | 00 | Kajian Risiko Mutu | 20-09-2019 | Berlaku | ||
| Formulir | FPE044 | 01 | Pemusnahan Retained Sampel Psikotropika, Prekursor, OOT | 22-08-2022 | Berlaku | ||
| Formulir | FPO001 | 03 | Daftar Periksa Catatan Produksi Bets | 22-06-2020 | Berlaku | ||
| Formulir | FPO002 | 01 | Serah Terima Dokumen Pelulusan Bets Produk | 06-07-2020 | Berlaku | ||
| Formulir | FPO003 | 00 | Log Book Pemusnahan Dokumen Pelulusan Bets Produk | 06-07-2020 | Berlaku | ||
| Formulir | FPO004 | 01 | Tanggapan Bidang | 07-02-2023 | Berlaku | ||
| Formulir | FQS004 | 02 | Log Book Ruangan | 23-08-2018 | Berlaku | ||
| Formulir | FQS005 | 02 | Log Book Mesin/Peralatan/Instrumen | 23-08-2018 | Berlaku | ||
| Formulir | FQS006 | 03 | Log Book Timbangan | 14-02-2020 | Berlaku | ||
| Formulir | FQS025 | 01 | Timeline Rencana Pengembangan Fasilitas | 09-12-2019 | Berlaku | ||
| Formulir | FQS026 | 01 | Registrasi Risiko Mutu | 29-03-2019 | Berlaku | ||
| Formulir | FQS032 | 01 | Pemantauan Kondisi Filter Dispensing Booth | 30-01-2020 | Berlaku | ||
| Formulir | FQS038 | 02 | Log Book Timbangan Laboratorium Pengawasan Mutu | 28-11-2019 | Berlaku | ||
| Manual Mutu | MM2018 | 01 | Manual Mutu | 30-08-2019 | Berlaku | ||
| Instruksi Kerja | PPE003 | 10 | Cara Penyimpanan Retained Sample | 05-06-2023 | Berlaku | ||
| Instruksi Kerja | PPE004 | 12 | Cara Pengambilan Retained Sample | 14-08-2023 | Berlaku | ||
| Instruksi Kerja | PPE015 | 00 | Cara Penyusunan Quality Agreement | 30-08-2023 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.04.25-0056 | 00 | Sertifikat CPOB Tablet Nonbetalaktam | 08-04-2025 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.04.25-0057 | 00 | Sertifikat CPOB Kapsul Keras Nonbetalaktam | 08-04-2025 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.04.25-0058 | 00 | Sertifikat CPOB Serbuk Oral Nonbetalaktam | 08-04-2025 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.04.25-0059 | 00 | Sertifikat CPOB Cairan Oral Nonbetalaktam | 08-04-2025 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.04.25-0073 | 00 | Sertifikat CPOB Semisolid Nonbetalaktam | 08-04-2025 | Berlaku | ||
| Sertifikat | PW-S.01.04.1.3.331.06.24.-0085 | 00 | Sertifikat CPOB Injeksi Volume Kecil Nonbetalaktam | 28-05-2024 | Berlaku | ||
| Prosedur | QUA-08 | 00 | Uji Stabilitas Produk Skala Komersial | 01-09-2023 | Berlaku | ||
| Instruksi Kerja | QUA00-P001 | 00 | Pemantauan Kondisi Lingkungan | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R001 | 00 | Pemantauan Lingkungan Kelas A-B-C | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R002 | 00 | Pemantauan Lingkungan Kelas D | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R003 | 00 | Pemantauan Lingkungan Kelas E | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R004 | 00 | Pemantauan Lingkungan Kelas F dan Laboratorium | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R005 | 00 | Pemantauan Lingkungan Gudang Non AC | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R006 | 00 | Pemantauan Lingkungan Gudang AC | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R007 | 00 | Pemantauan Lingkungan Produksi Herbal Kelas 1 | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R008 | 00 | Pemantauan Lingkungan Produksi Herbal Kelas 2 | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R009 | 00 | Pemantauan Lingkungan Produksi Herbal Kelas 2 Ekstraksi | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R010 | 00 | Pemantauan Lingkungan Produksi Herbal Kelas 2B | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R011 | 00 | Pemantauan Lingkungan Freezer | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R012 | 00 | Pemantauan Lingkungan Inkubator | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R013 | 00 | Pemantauan Lingkungan Inkubator Strest Test | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R014 | 00 | Pemantauan Lingkungan Refrigrator | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R015 | 00 | Pemantauan Lingkungan Climatic Chamber Stabilitas Dipercepat | 24-01-2025 | Berlaku | ||
| Rekaman | QUA00-P001-R016 | 00 | Pemantauan Lingkungan Climatic Chamber Stabilitas Real Time | 24-01-2025 | Berlaku | ||
| Instruksi Kerja | QUA01-P001 | 01 | Sistem Dokumentasi | 11-03-2025 | Berlaku | ||
| Formulir | QUA01-P001-F001 | 00 | Memo | 27-10-2023 | Berlaku | ||
| Formulir | QUA01-P001-F002 | 00 | Daftar Hadir | 27-10-2023 | Berlaku | ||
| Formulir | QUA01-P001-F003 | 00 | Risalah Rapat | 27-10-2023 | Berlaku | ||
| Formulir | QUA01-P001-F004 | 00 | Berita Acara Pemusnahan Dokumen | 27-10-2023 | Berlaku | ||
| Rekaman | QUA01-P001-R001 | 00 | Pengendalian Distribusi Dokumen | 27-10-2023 | Berlaku | ||
| Rekaman | QUA01-P001-R002 | 00 | Pengendalian Penggunaan Rekaman | 27-10-2023 | Berlaku | ||
| Instruksi Kerja | QUA02-P001 | 00 | Penggunaan Aplikasi e-Key Performance Indicator | 28-11-2023 | Berlaku | ||
| Instruksi Kerja | QUA04-P001 | 00 | Pelaksanaan Audit | 17-07-2024 | Berlaku | ||
| Daftar | QUA04-P001-D001 | 00 | Auditor Internal | 04-02-2025 | Berlaku | ||
| Rekaman | QUA04-P002-R001 | 00 | Kualifikasi Personil | 04-12-2024 | Berlaku | ||
| Rekaman | QUA04-P002-R002 | 00 | Rekam Jejak Aktivitas Pelatihan Personil | 04-12-2024 | Berlaku | ||
| Instruksi Kerja | QUA05-P014 | 00 | Cara Penentuan Minimum Weight | 22-01-2025 | Berlaku | ||
| Instruksi Kerja | QUA06-P001 | 00 | Pelaksanaan Validasi | 12-09-2024 | Berlaku | ||
| Instruksi Kerja | QUA06-P004 | 00 | Pelaksanaan Kualifikasi | 24-01-2025 | Berlaku | ||
| Instruksi Kerja | QUA06-P005 | 00 | Panduan Penyusunan Protokol dan Laporan Kualifikasi Mesin dan Saran Penunjang | 24-03-2025 | Berlaku | ||
| Prosedur | QUA07 | 00 | Penanganan Keluhan dan Penarikan Produk | 05-01-2024 | Berlaku | ||
| Instruksi Kerja | QUA07-P001 | 00 | Penanganan Keluhan dan Penarikan Produk | 06-12-2024 | Berlaku | ||
| Instruksi Kerja | QUA07-P002 | 00 | Mock Recall | 05-02-2025 | Berlaku | ||
| Instruksi Kerja | QUA07-P004 | 00 | Product Quality Review | 05-03-2025 | Berlaku | ||
| Formulir | QUA07-P004-F001 | 00 | Prioritas Product Quality Review | 05-03-2025 | Berlaku | ||
| Formulir | QUA07-P004-F002 | 00 | Jadwal Rencana Product Quality Review | 05-03-2025 | Berlaku | ||
| Prosedur | QUA09 | 00 | Disposisi Bets Produk | 05-01-2024 | Berlaku | ||
| Instruksi Kerja | QUA09-P001 | 00 | Evaluasi dan Pengelolaan Dokumen Pelulusan Bets Produk | 12-12-2023 | Berlaku | ||
| Rekaman | QUA09-P001-R001 | 00 | Daftar Periksa Dokumen Pelulusan Produk | 12-12-2023 | Berlaku | ||
| Rekaman | QUA09-P001-R002 | 00 | Daftar Periksa Dokumen Pelulusan Produk Impor | 04-12-2023 | Berlaku | ||
| Rekaman | QUA09-P001-R003 | 00 | Daftar Periksa Catatan Produksi Bets | 12-12-2023 | Berlaku | ||
| Rekaman | QUA09-P001-R004 | 00 | Log Book Pemusnahan Dokumen Pelulusan Bets Produk | 04-12-2023 | Berlaku | ||
| Instruksi Kerja | QUA10-P001 | 00 | Penanganan Penyimpangan | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R001 | 00 | Catatan Penyimpangan | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R002 | 00 | Tanggapan Divisi | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R003 | 00 | Kajian Penyimpangan Awal | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R004 | 00 | Kajian Penyimpangan Lanjutan | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R005 | 00 | Kontrol Penyimpangan | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R006 | 00 | Investigasi Penyimpangan | 27-11-2023 | Berlaku | ||
| Rekaman | QUA10-P001-R007 | 00 | Kronologis Kejadian | 27-11-2023 | Berlaku | ||
| Instruksi Kerja | QUA11-P001 | 01 | Pengelolaan Perubahan | 25-04-2025 | Berlaku | ||
| Rekaman | QUA11-P001-R001 | 00 | Usulan Perubahan | 21-10-2024 | Berlaku | ||
| Rekaman | QUA11-P001-R002 | 00 | Tanggapan Divisi | 21-10-2024 | Berlaku | ||
| Rekaman | QUA11-P001-R003 | 00 | Kanjian Perubahan | 21-10-2024 | Berlaku | ||
| Rekaman | QUA11-P001-R004 | 00 | Kontrol Perubahan | 21-10-2024 | Berlaku | ||
| Rekaman | RKV01 | 00 | Kompetensi Teknik Personil Bidang Pemastian Mutu Seksi Kalibrasi, Kualifikasi & Validasi | 11-12-2018 | Berlaku | ||
| Rekaman | RKVK01 | 00 | Kriteria Penerimaan Hasil Kalibrasi Ekternal | 29-10-2018 | Berlaku | ||
| Rekaman | RPO001 | 00 | Kompetensi Teknik Personil Bidang Pemastian Mutu Seksi Pelulusan Produk | 12-12-2018 | Berlaku | ||
| Rekaman | RQS001 | 00 | Kompetensi Teknik Personil Bidang Pemastian Mutu Seksi Pengembangan Sistem | 11-12-2018 | Berlaku | ||
| Rekaman | RQS002 | 00 | Kompetensi Asisten Manajer Bidang Pemastian Mutu | 02-01-2020 | Berlaku | ||
| Ketentuan Umum | XPE019 | 06 | Pemantauan Vigilans Produk | 11-05-2023 | Berlaku |
Hal: 1 |
