Lampiran 1. Struktur Organisasi PT MUTIFA
DIREKTUR UTAMA JACOB LIE FINANCE GENERAL MGR Ir. TIMOTIUS MGR QA BETTY, Apt SUPERVISOR QA MGR R&D D.R. NAINGGOLAN, Apt MGR REGISTRASI Dra. NURANTI MGR PRODUKSI NBL BUDIONO, Apt MGR PRODUKSI BL & PKRT DONALD, Apt MGR QC RITA PUSPITA, Apt MGR TEKNIK ARIF NASUTION, ST MGR PENJUALAN & PPIC HIDAYAT N, SE MGR PEMBELIAN & S.A. PERSONALIAAMIRUDDIN, SH
MGR KEUANGAN AGNES, SE
SUPERVISOR R&D VIVI, S. Farm, Apt
SUPERVISOR PRODUKSI ERIKA HUTAJULU S. Farm , Apt SUPERVISOR QC MELYA UTAMI, S. Farm, Apt SUPERVISOR TEKNIK KABAG PPIC
STAF AHLI CPOB TEKNIK KEPALA UNIT SIRUP KEPALA UNIT PENGOLAHAN TABLET KEPALA UNIT PENGEMASAN PRIMER S.PDT & PRODUK SISA KEPALA UNIT PENGEMASAN KEPALA GUDANG BAHAN KEMASAN KEPALA GUDANG BAHAN BAKU KEPALA GUDANG OBAT JADI
Lampiran 2. Bagan Proses Pembuatan Tablet/ Kaplet
Pencampuran Penimbangan
Cetak tidak langsung
Granulasi basah Granulasi kering Lubrikasi/ penambahan bahan pelicin Pencetakan Pengemasan
Gudang Hasil Jadi
Slugging
Pengeringan di oven suhu 60o
IPC : LOD
IPC : Kadar zat berkhasiat Karantina
Karantina Karantina IPC : - Pemerian - Diameter - Friabilitas - Keseragaman bobot - Waktu hancur - Tebal - Kekerasan
- Kadar zat berkhasiat k l
Lampiran 3. Bagan Proses Pembuatan Kapsul
Pengisian ke cangkang kapsul Pengeringan dan Pencampuran
Penimbangan
Pengemasan
Gudang Hasil Jadi IPC : Kadar zat berkhasiat
IPC : - Suhu - Kelembaban maks 50% Seleksi Karantina Karantina IPC :
- Kadar zat berkhasiat - Waktu hancur - Keseragaman bobot - Disolusi
Lampiran 4. Bagan Proses Pembuatan Serbuk Oral
Penimbangan
Pengemasan
Gudang Hasil Jadi IPC : Kadar zat berkhasiat
IPC :
- Keseragaman bobot - Kadar zat aktif
Pengisian ke wadah
Karantina
Karantina
Finished Pack Analysis
Karantina Pengeringan
IPC : LOD
Pencampuran
Lampiran 5. Bagan Proses Pembuatan Liquida
Penimbangan
Pengemasan
Gudang Obat Jadi IPC :
- Keseragaman volume - Kadar zat berkhasiat - Kebocoran wadah Karantina Karantina IPC : - pH larutan - BJ
- Kadar zat berkhasiat - Viskositas
Finished Pack Analysis Karantina
Pelarutan
Pencampuran
Penyaringan
Lampiran 6. Bagan Proses Pembuatan Salep
Penimbangan
Pengemasan
Gudang Obat Jadi IPC :
- Keseragaman bobot - Kadar zat berkhasiat
Karantina
Karantina IPC :
- Kadar zat berkhasiat - Homogenitas
Finished Pack Analysis Karantina
Pencampuran dengan mixer
Lampiran 7. Bagan Proses Pembuatan Tablet Salut Gula
Penimbangan Pencampuran Granulasi basah Pengeringan di FBD 600C, 30 menit Granulasi kering IPC : LODKarantina Produk Antara
Karantina Produk Ruahan Pencetakan IPC :
Kadar zat berkhasiat LOD Pemerian IPC : Pemerian Friabilitas Keseragaman bobot Waktu hancur Kekerasan Ketebalan Disolusi Sealing Subcoating Smoothing Polishing IPC : Homogenitas warna Keseragaman bobot
Waktu hancur Sortir
Pengemasan
Karantina obat jadi
Gudang obat jadi
Finished Pack Analysis
Pengeringan di Oven pada suhu 350C ,7 jam Lubrikasi/penambahan bahan pelicin
Lampiran 8. Daftar Data Produk PT. MUTIFA
No.
Nama Obat
Kemasan
Komposisi
TABLET
1. Omecal-D Tab/10 x 10 strip CaCO3, Vit D
2. Omecold Tab/10 x 10 strip Paracetamol, phenylpropanolamin HCl, Chlorpheniramine maleat
3. Omedeson 0,5 mg Pot/1000’s Dexamethason 4. Omedeson 0,5 mg Box/10 x 20 strip Dexamethason 5. Omedom 10 mg Tab/10 x 10 strip Domperidon 6. Omegastri Sugar Coated Box/10 x 10
strip
Klordiazopoksida, klidinium bromida
7. Omegdiar (kaolin+pectin) Box/10 x 10 strip Kaolin, pectin 8. Omegdiar (kaolin+pectin) Pot/1000’s Kaolin, pectin
9. Omegesic F.C 500 mg Box/10 x 10 strip Metampiron, Vit B1, Vit B6, Vit B12 10. Omegfantrin 125 mg Box/4 x 25 blister Pyrantel pamoat
11. Omegfantrin 250 mg Box/2 x 25 blister Pyrantel pamoat 12. Omegrip 500 mg Box/10 x 10 strip Paracetamol
13. Omegtamine Box/10 x 30 strip Dexamethason, Dexchlorfeniramine maleat
14. Omegtrim adult 480 mg Box/10 x 10 strip Trimethoprim, Sulphametoxazole 15. Omegzole 200 mg Tab/10 x 10 strip Ketokonazole
16. Omemox 250 mg Box/10 x 10 kaplet Amoxyciline 17. Omemox 500 mg Box/10 x 10 strip Amoxyciline 18. Omenacort 4 mg Tab/10 x 10 strip Triamcinolone
19. Omeneuron Box/10 x 10 strip Vit B1, Vit B6, Vit B12
20. Omeproksil 500 mg Box/10 x 10 strip Cyprofloxacine HCl monohidrat 21. Omeric 100 mg Box/10 x 10 strip Allopurinol
22. Omeric 300 mg Box/10 x 10 strip Allopurinol 23. Omeroxol 30 mg Tab/10 x 10 strip Ambroxol HCl 24. Omesip 4 mg sugar coated Tab/10 x 10 strip Siproheptadine HCl 25. Omestan F.C 500 mg Box/10 x 10 blister Asam mefenamat 26. Ometilson 4 mg Kapl/10 x 10 strip Metilprednisolon 27. Omevomid 10 mg Tab/10 x 10 strip Metoclopramide 28. Panviton kapl. Ekstrak
Ginseng
Box/10 x 5 kaplet Curcumae, Ekstrak ginseng, Vit C, Vit B1, Vit B6, Vit B12, Nikotinamid, Ca-pantothenat, Mn (II), Cu, Co, Ca, Mg, Zink
29. Stomach tablet Box/10 x 10 tablet Aluminium hidroksida2, Magnesium hidroksida2, simetikon
30. Omedrinat Box/10 x 10 tablet Dimenhidrinat 31. Omegluphage Dus/10 x 10 strip Metformin HCl 32. Omekur Dus/10 x 10 strip Cimetidine 33. Omenizol Dus/10 x 10 strip Metronidazol 34. Omeramine F.C 150 mg Dus/10 x 10 strip Ranitidin HCl 35. Omeretic tab Dus/10 x 10 strip Piroksikam 36. Omesolvon Box 10 strip x 10
tablet
tablet
38. Panvit-C kaplet Dus/10 x 10 strip Vit C, Vit B1, Vit B2, Vit B3 (nikotinamid), Vit B5 (Kalsium panthotenat), Vit B6, Vit B12
39. Vilergi Dus/10 x 10 strip Dexchlorfeniramine maleat
40. Vitalamin Gold kaplet Dus/10 x 10 strip Vit A, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Vit D, Kalsium pantotenat, Nikotinamid, Asam folat, Fe(II) Fumarat, ZnSO4, CuSO4, MnSO4
41. Vitalamin Gold kaplet Botol 500 kaplet Vit A, Vit B1, Vit B2, Vit B6, Vit B12, Vit C,Vit D, Kalsium pantotenat, nikotinamid, asam folat, Fe(II) Fumarat, ZnSO4, CuSO4, MnSO4
42. Vitalamin kaplet Botol 500 kaplet Vit A, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Vit D, Kalsium pantotenat, Nikotinamid, Asam folat, Fe(II) Fumarat
43. Vitalamin kaplet Dus/10 x 10 strip Vit A, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Vit D, Kalsium pantotenat, nikotinamid, asam folat, Fe(II) Fumarat 44. Vitamin A 5.000 IU Kaleng 1000 tablet Vitamin A 5.000 IU
45. Antacida (magcumalu) Pot/1000’s Aluminium hidroksida, Magnesium hidroksida
46. Ampicillin 250 mg Box/10 x 10 kaplet Ampicillin tririhidrat 47. Ampicillin 500 mg Box/10 x 10 kaplet Ampicillin tririhidrat 48. Antalgin 500 mg Box/10 x 20 strip Antalgin
49. Antalgin 500 mg Pot /1000’s Antalgin
50. CTM 4 mg Pot /1000’s Chlorpheniramin maleat 51. Chloroquin Pot /1000’s Chloroquin difosfat 52. Gliseril Guaikolat 100 mg Pot /1000’s Gliseril guaikolat 53. INH 100 mg Pot /1000’s Isoniazida 54. Metronidazol 250 mg Box/10 x 10 strip Metronidazol 55. Metronidazol 500 mg Box/10 x 10 strip Metronidazol 56. Papaverin HCl 40 mg Pot /1000’s Papaverin HC 57. Paracetamol 500 mg Pot /1000’s Paracetamol 58. Paracetamol 500 mg Box/10 x 20 strip Paracetamol
59. Prednison Pot /1000’s Prednison
60. Trisulfa Pot /1000’s Sulfadiazina,Sulfametazin, sulfasomidina
61. Vitamin B komplex Pot /1000’s Vit B1, Vit B2, Vit B5, Vit B6 62. Vitamin B1-50 mg Pot /1000’s Vit B1
63. Vitamin B6-10 mg Pot /1000’s Vit B6
SYRUP
1. Anak Mas Botol 60 ml Asetaminofen, Koffein, CTM 2. Chloramfenikol suspensi Botol 60 ml Kloramfenikol palmitat
3. Curbion Botol 60 ml Betakaroten, Curcumae, Biotin, Lysin HCl, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12
4. Curbion cod liver oil kids E Botol 60 ml Vit A, Vit D, DHA, EPA, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Biotin, Lysin HCl, Betakaroten 5. Curbion cod liver oil kids E Botol 100 ml Vit A, Vit D, DHA, EPA, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5,
Vit B6, Biotin, Lysin HCl, Betakaroten, Kalsium, Asam folat, Asam L glutamat
6. Curbion cod liver oil kids E Botol 200 ml Vit A, Vit D, DHA, EPA, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Biotin, Lysin HCl, Betakaroten, Kalsium, Asam folat, Asam L glutamat
7. Curbion Fit Botol 100 ml Echianaceae, Zink, Pikolinat, Selenium, Vit C, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, DHA, EPA, Royal Jelly, Minyak ikan cod
8. Curbion Fit Botol 60 ml Echianaceae, Zink, Pikolinat, Selenium, Vit C, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, DHA, EPA, Royal Jelly, Minyak ikan cod
9. Curbion Fit Botol 200 ml Echianaceae, Zink, Pikolinat, Selenium, Vit C, Curcumae ext, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, DHA, EPA, Royal Jelly, Minyak ikan cod
10. Curbion Hi- DHA syrup Botol 60 ml Vit A, Vit D, DHA, EPA, Curcumae ext, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Lysin HCl, Betakaroten, Kalsium, Asam folat, Asam L glutamat
11. Curbion Hi- DHA syrup Botol 100 ml Vit A, Vit D, DHA, EPA, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Lysin HCl, Betakaroten, Kalsium, Asam folat, Asam L glutamat
12. Curbion Supra Botol 60 ml Fe, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B6, Asam folat, Biotin, Royal Jelly, Minyak ikan cod
13. Curbion Supra Botol 100 ml Fe, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B6, Asam folat, Biotin, Royal Jelly, Minyak ikan cod
14. Curbion Supra Botol 200 ml Fe, Curcumae extract, Vit B1, Vit B2, Vit B3, Vit B6, Asam folat, Biotin, Royal Jelly, Minyak ikan cod
15. Dextrometorfan HBr syrup kaca
Botol 100 ml Dextrometorfan HBr 16. Dextrometorfan HBr syrup OGB
plastik
Botol 60 ml Dextrometorfan HBr
17. Obat batuk hitam Botol 100 ml Glycirhizae succus, Ammonium chlorida, Olium anisi, Antimon liquida 18. Omecough Botol 60 ml Dextrometorfan HBr, Paracetamol,
Gliseril guaikolat, Chlorpheniramin maleat
19. Omedom Botol 60 ml Domperidon
20. Omegdiar suspensi Botol 60 ml Kaolin, pectin
B6, Vit B12, Vit C, Niacinamide, Ca-panthothenate, L-Lysin HCl, Ca- glycerolfosfat
23. Omemox dry syrup Botol 60 ml Amosisilin trihidrat
24. Omeroxol Botol 60 ml Ambroxol HCl
25. Omesolvon Botol 60 ml Bromheksin HCl, Gliseril guaikolat, Etanol 3,72% v/v
26. Ometridryl Botol 60 ml Diphenhydramine HCl, Ammonium chlorida, Menthol, Na sitrat, Dextrometorfan HBr
27. Omevita syrup Botol 60 ml Vit A, Vit D, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Niacinamide, Ca-panthothenate, L-Lysin HCl
28. Omevita syrup Botol 100 ml Vit A, Vit D, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Niacinamide, Ca-panthothenate, L-Lysin HCl
29. Omevomid Botol 60 ml Metoklopramide HCl
30. Pantonik syrup ginseng extra Botol 300 ml Ginseng extract, Vit B1, Vit B2, Vit B6, Vit B12, Vit C, Niacinamide, Ca-panthothenate, Liver extract, Mn(II), Fe(II)
31. Paracetamol 60 ml kaca Botol 60 ml Paracetamol 32. Paracetamol OGB plastik Botol 60 ml Paracetamol
33. Tusselix Botol 100 ml Ephedrin HCl, CTM, Glycirhizae succus, Ammonium chlorida
KAPSUL
1. Chloramphenicol 250 mg Pot/1000’s Chloramphenicol
2. Ginconax Botol/30’s Extract Ginko Biloba, extract panax ginseng
3. Omegavit Box/10 x 10 strip Ferros glukonas, Magnesium sulfat, Copper sulphate, Vit C, Vit B12, As folat
4. Omeginko kapsul Box strip, 10
kapsul
Ginko Biloba, Asam L-glutamat, Vit B1, Vit B6, Vit E, Vit B12
5. Omeretik 20 mg Box/10 x 10 strip Piroksikam 6. Omestan 250 mg Box/10 x 10 strip Asam mefenamat 7. Tetracycline 250 mg Pot/1000’s Tetracycline HCl
8. Turtensi Botol/30’s Alii sativi bulbus, Apium graveolus folium ext, Phylanthi herba ext, Cantella herba ext, Ortosiphonis folium ext, curcumae rhyzoma ext, Imperatae radix ext
9. Vidabion Cal Box/10 x 10 strip Ferrous fumarate, As folat, CaCO3, Vit B12, Cholecalciferol, ascorbic acid
CAIRAN/SALEP/SER
BUK
1. Salp 2-4/pot 30 g Box/@ 12 pot Asam salisilat, belerang endap 2. Whitfield salp 30 g Box/@ 12 pot Asam benzoat, Asam salisilat 3. Bedak salisil 2% Ktk/@ 50 g Acidum salisilicum
MINUMAN
BERKHASIAT
1. X- prim spirit Cup plastik 200 ml 1, 3, 7 trimethylxantin, Taurin, Ginseng
jelly, Vit B1, Vit B2, Vit B3, Vit B6 2. X- prim red Cup plastik 200 ml 1, 3, 7 trimethylxantin, Taurin, Ginseng
ext, Glutamin, Inositol, L-carnitine, Royal jelly, Vit B1, Vit B2, Vit B3, Vit B6
3. Vitasus cairan Botol 100 ml Vit A, Vit D, Vit E, Vit C, Vit K, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Asam folat, Kolin, Inositol, Taurin Karnitin, Natrium, Kalium, Klorida, Kalsium, Fosfor, Magnesium, Besi, Zink, Mangan, Copper, Iodida, Selenium, Kromium, Molibdat
4. Vitasus cairan Botol 200 ml Vit A, Vit D, Vit E, Vit C, Vit K, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Asam folat, Kolin, Inositol, Taurin, Karnitin, Natrium, Kalium, Klorida, Kalsium, Fosfor, Magnesium, Besi, Zink, Mangan, Copper, Iodida, Selenium, Kromium, Molibdat
5. Vitasus cairan Botol 500 ml Vit A, Vit D, Vit E, Vit C, Vit K, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Asam folat, Kolin, Inositol, Taurin, Karnitin, Natrium, Kalium, Klorida, Kalsium, Fosfor, Magnesium, Besi, Zink, Mangan, Copper, Iodida, Selenium, Kromium, Molibdat
6. Vitasus rasa vanila Serbuk sacc @ 40 g
Vit A, Vit D, Vit E, Vit C, Vit K, Vit B1, Vit B2, Vit B3, Vit B5, Vit B6, Vit B12, Biotin, Asam folat, Kolin, Inositol, Taurin, Karnitin, Natrium, Kalium, Klorida, Kalsium, Fosfor, Magnesium, Besi, Zink, Mangan, Copper, Iodida, Kromium, Selenium, Molibdat