PT. Fresenius Kabi Combiphar PT.

Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Inkjet Printer Hitachi B : Timbangan Sartorius 150 kg
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-006 B : PROD-P-11-013
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: RPQ-11-003B : XXQ-11-013
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 28.07.2011 : 19.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 25.07.2017 : 18.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 25.07.2020 : 18.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat : Timbangan Sartorius BSA
: Weighing Booth
(Machine/equipment name) (Machine/equipment name) 5201
No.Asset No.Asset
: PROD-P-11-018 : PROD-P-11-016
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: RPQ-11-006 : XXQ-11-016
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 07.06.2011 : 19.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 06.06.2017 : 18.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 06.06.2020 : 18.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Stripping Machine : Vacuum Tester
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-005 : PROD-P-11-007
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: RPQ-11-005 : RPQ-11-007
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 25.07.2011 : 22.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 25.07.2017 : 21.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 25.07.2020 : 21.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat : Timbangan Sartorius BSA Nama mesin/Alat
(Machine/equipment name) : Inkjet Printer Hitachi A
2235 (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-015 A : PROD-P-11-006 A
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: XXQ-11-015 A : RPQ-11-003 A
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 19.07.2011 : 26.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 18.07.2017 : 25.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 18.07.2020 : 25.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Tableting Machine : Metal Detector
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-001 : PROD-P-11-003
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: RPQ-11-001 : RPQ-11-002
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 23.07.2014 : 24.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 21.07.2017 : 24.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 21.07.2020 : 24.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Magnehelic R. Tabletting : Magnehelic 1 Weighing Booth
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-M-11-009C : PROD-P-11-018
(Asset No.) (Asset No.)
No.Laporan : F.0194/IK/QAC/09/6.3- No.Laporan
: F.01B/IK/TEK/06/7.6-0/001D
(Report No.) 5/077Ed:A (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 22.09.2016 : 26.09.2016
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 22.09.2017 : 26.09.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: Pressure : Tekanan
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Magnehelic R. Coating : Big Ultra Thurax (rotation)
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-M-11-009D : PROD-P-11-011-1
(Asset No.) (Asset No.)
No.Laporan : F.0194/IK/QAC/09/6.3- No.Laporan
: F.01B/IK/TEK/06/7.6-0/004C
(Report No.) 5/077Ed:A (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 22.09.2016 : 26.09.2016
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 22.09.2017 : 26.09.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: Pressure : Rotasi (rpm)
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat : Magnehelic Raw Material Nama mesin/Alat
: Magnehelic R. Stripping
(Machine/equipment name) Airlock (Machine/equipment name)
No.Asset No.Asset
: PROD-M-11-009F : PROD-M-11-009E
(Asset No.) (Asset No.)
No.Laporan : F.0194/IK/QAC/09/6.3- No.Laporan : F.0194/IK/QAC/09/6.3-
(Report No.) (Report No.) 5/077Ed:A
5/077Ed:A
Tanggal Kualifikasi Tanggal Kualifikasi
: 22.09.2016 : 22.09.2016
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 22.09.2017 : 22.09.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: Pressure : Pressure
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKALIBRASI TERKALIBRASI
(CALIBRATED) (CALIBRATED)
Nama mesin/Alat Nama mesin/Alat
: Thermocouple A Mesin Stripping : Turet Tableting Machine
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-005-1 : PROD-P-11-001
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: F117/IK/QAC/09/7.6-0/022 : F.01B/IK/TEK/06/7.6-0/004C
(Report No.) (Report No.)
Tanggal kalibrasi Tanggal kalibrasi
: 29.09.2016 : 04.10.2016
(Calibration date) (Calibration date)
Tanggal kalibrasi ulang Tanggal kalibrasi ulang
: 29.09.2017 : 04.10.2017
(Re-Calibration date) (Re-Calibration date)
Parameter Parameter
: Suhu : Rotasi 9rpm)
(Parameter) (Parameter)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKALIBRASI TERKALIBRASI
(CALIBRATED) (CALIBRATED)
Nama mesin/Alat Nama mesin/Alat
: Thermocouple B Mesin Stripping : Pressure Gauge Tablet Deduster
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-005-2 : PROD-P-11-011-2
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: F117/IK/QAC/09/7.6-0/022 : F.01B/IK/TEK/06/7.6-0/001D
(Report No.) (Report No.)
Tanggal kalibrasi Tanggal kalibrasi
: 29.09.2016 : 04.10.2016
(Calibration date) (Calibration date)
Tanggal kalibrasi ulang Tanggal kalibrasi ulang
: 29.09.2017 : 04.10.2017
(Re-Calibration date) (Re-Calibration date)
Parameter Parameter
: Suhu : Pressure
(Parameter) (Parameter)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKALIBRASI TERKALIBRASI
(CALIBRATED) (CALIBRATED)
Nama mesin/Alat Nama mesin/Alat
: Magnehelic 2 Weighing Booth : Big Ultra Thurax (rotation)
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-018-2 : PROD-P-11-011-1
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: F194/IK/QAC/09/6.3-5/077 Ed.:A : F.01B/IK/TEK/06/7.6-0/004C
(Report No.) (Report No.)
Tanggal kalibrasi Tanggal kalibrasi
: 29.09.2016 : 29.09.2016
(Calibration date) (Calibration date)
Tanggal kalibrasi ulang Tanggal kalibrasi ulang
: 29.09.2017 : 29.09.2017
(Re-Calibration date) (Re-Calibration date)
Parameter Parameter
: Pressure : Rotasi (rpm)
(Parameter) (Parameter)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKALIBRASI TERKALIBRASI
(CALIBRATED) (CALIBRATED)
Nama mesin/Alat Nama mesin/Alat
: Magnehelic 1 Weighing Booth : Big Ultra Thurax (timer)
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-018-1 : PROD-P-11-011-2
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: F194/IK/QAC/09/6.3-5/077 Ed.:A : F.214/IK/QAC/09/7.6-0/023 Ed.:A
(Report No.) (Report No.)
Tanggal kalibrasi Tanggal kalibrasi
: 29.09.2016 : 29.09.2016
(Calibration date) (Calibration date)
Tanggal kalibrasi ulang Tanggal kalibrasi ulang
: 29.09.2017 : 29.09.2017
(Re-Calibration date) (Re-Calibration date)
Parameter Parameter
: Pressure : Waktu
(Parameter) (Parameter)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Inkjet Printer Imaje 9020 : Disintegration tester
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-14-027 : PROD-P-11-008
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: RPQ-14-001 : ROQ-11-009
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 19.06.2014 : 19.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 19.06.2017 : 19.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 19.06.2020 : 19.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat : Timbangan Sartorius BSA Nama mesin/Alat
: Ultra Thurax
(Machine/equipment name) 5200 (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-016 : PROD-P-11-011
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: XXQ-11-016 : FRQ-14-007
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 19.07.2011 : 18.07.2014
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 18.07.2017 : 18.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 18.07.2020 : 18.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat Nama mesin/Alat
: Timbangan Sartorius 15 kg : Timbangan Sartorius BSA 220
(Machine/equipment name) (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-014 : PROD-P-11-015 B
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: XXQ-11-014 : XXQ-11-1015 B
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal kalibrasi
: 19.07.2011 :19.07.2011
(Qualification date) (Calibration date)
Tanggal review kualifikasi Tanggal kalibrasi ulang
: 18.07.2017 : 18.07.2017
(Qualification review date) (Re-Calibration date)
Review Kualifikasi berikutnya Parameter
: 18.07.2020 : 18.07.2020
(Next qualification review date) (Parameter)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar PT. Fresenius Kabi Combiphar

TERKUALIFIKASI TERKUALIFIKASI
(QUALIFIED) (QUALIFIED)
Nama mesin/Alat : Timbangan Sartorius BSA Nama mesin/Alat
: Hardness Tester
(Machine/equipment name) 223S (Machine/equipment name)
No.Asset No.Asset
: PROD-P-11-015 A : PROD-P-11-009
(Asset No.) (Asset No.)
No.Laporan No.Laporan
: XXQ-11-015 A : ROQ-11-008
(Report No.) (Report No.)
Tanggal Kualifikasi Tanggal Kualifikasi
: 19.07.2011 : 19.07.2011
(Qualification date) (Qualification date)
Tanggal review kualifikasi Tanggal review kualifikasi
: 18.07.2017 : 19.07.2017
(Qualification review date) (Qualification review date)
Review Kualifikasi berikutnya Review Kualifikasi berikutnya
: 18.07.2020 : 19.07.2020
(Next qualification review date) (Next qualification review date)
Paraf / tgl Paraf / tgl
: :
(Sign/date) (Sign/date)
No. L.011.01 No. L.011.01
PT. Fresenius Kabi Combiphar

TERKUALIFIKASI
(QUALIFIED)
Nama mesin/Alat
: Coating Machine
(Machine/equipment name)
No.Asset
: PROD-P-11-004
(Asset No.)
No.Laporan
: RPQ-11-004
(Report No.)
Tanggal Kualifikasi
: 29.07.2011
(Qualification date)
Tanggal review kualifikasi
: 28.07.2017
(Qualification review date)
Review Kualifikasi berikutnya
: 28.07.2020.
(Next qualification review date)
Paraf / tgl
:
(Sign/date)
No. L.011.01
PT. Fresenius Kabi Combiphar

TERKUALIFIKASI
(QUALIFIED)
Nama mesin/Alat
: Friability Tester
(Machine/equipment name)
No.Asset
: PROD-P-11-010
(Asset No.)
No.Laporan
: ROQ-11-011
(Report No.)
Tanggal Kualifikasi
: 26.07.2011
(Qualification date)
Tanggal review kualifikasi
: 26.07.2017
(Qualification review date)
Review Kualifikasi berikutnya
: 26.07.2020
(Next qualification review date)
Paraf / tgl
:
(Sign/date)
No. L.011.01