Laporan Prakerin SMK Analis Kimia Tunas Harapan - Zeffa Aprilasani

PENETAPAN KADAR PARASETAMOL DALAM SEDIAAN KAPLET

LAPORAN PRAKTIK KERJA INDUSTRI

Tugas Akhir Diajukan Sebagai Salah Satu Syarat Mengikuti Uji Kompetensi Sekolah Menengah Kejuruan Analis Kimia Tunas Harapan

Oleh :

Zeffa Aprilasani 432

SMK Analis Kimia Tunas Harapan Jl. Bendera Raya Intisari III Kalisari Pasar Rebo JAKARTA TIMUR   November 2007

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KATA PENGANTAR 

Lapora Laporan n Pengal Pengalama aman n Kerja Kerja Lapang Lapangan an di GlaxoS GlaxoSmit mithKl hKline ine ini disusu disusun n sebagai salah satu syarat untuk mengikuti ujian akhir SMK Analis Kimia Tunas Harapan dan juga sebagai hasil dari Prakerin yang telah dilaksanakan terhitung sejak 02 Juli 2007 sampai dengan 31 Agustus 2007. Adapun Adapun garis besar laporan laporan ini berisi pendahuluan, pendahuluan, struktur organisasi, organisasi, tinjauan pustaka, metode analisis, hasil pembahasan dan simpulan saran. Puji Puji syukur syukur kepada kepada Allah Allah SWT karena karena atas atas rahmat rahmat dan karuni karunia-Ny a-Nyaa   penu penulis lis dapat dapat menyel menyelesa esaika ikan n lapora laporan n Prakerin Prakerin ini. ini. Ucapan Ucapan terima terima kasih kasih saya saya haturkan untuk : 1. Seluruh Seluruh kelurga kelurga besar besar atas dukungan dukungan yang selalu selalu tercurah tercurah untuk untuk saya. saya. 2. Bapa Bapak k Eddy Eddy Jusuf Jusuf selaku selaku Kepala Kepala SMK SMK Anali Analiss Kimi Kimiaa Tuna Tunass Hara Harapa pan n  beserta seluruh staf atas bimbingannya selama mengikuti pendidikan. 3. Bapak apak Arsi Arsill

Had Hadjar jar

sela selaku ku mant mantan an Mana Manag ger Qual Qualit ity y

Assu Assura ran nce

GlaxoS GlaxoSmit mithKl hKline ine atas atas kesemp kesempatan atan yang yang telah telah diberik diberikan an pada pada saya saya untuk  untuk  melaksanakan prakerin di QA/QC GlaxoSmithKline. 4. Ibu

Yeti

Kartika

sobarin

selaku

Manager

Quality

Assurance

GlaxoSmithKline. 5. Ibu Intan Intan Maulina Maulina selaku selaku Pharmacis Pharmacistt Quality Assura Assurance nce GlaxoSmit GlaxoSmithKlin hKline. e. 6. Ibu Niken Niken selaku selaku pembim pembimbing bing di di sekolah sekolah yang yang telah memberi memberi arahan pada saya dalam pembuatan laporan. 7. Bapak Iman Iman Susanty Susantyo o selaku pembimbin pembimbing g di GlaxoSmith GlaxoSmithKline Kline atas atas segala segala ilmu, bantuan, dan bimbingannya selama saya melaksanakan prakerin . 8. Ibu Pupu Pupu Kurnia Kurniasih, sih, Bapak Bapak Iwan Iwan Hirawan, Hirawan, Bapak Bapak Fajar, Fajar, & Mba Mba Ariyani. Ariyani. 9. Mas Ihsan Ihsan,, Mas Mursid Mursid,, Mas Gofur, Gofur, & mas Maulana Maulana atas atas dukunga dukungan n dan  bantuan yang telah diberikan selama saya melaksanakan prakerin. 10. Mas Hepy Yuliana Yuliana (analis QA GSK) atas kebaikan kebaikan & bantuan nya pada pada saya saat melaksanakan prakerin, maupun dalam pembuatan laporan.

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Saya sebagai penyusun, menyadari laporan ini masih jauh dari sempurna. Maka Maka saya saya mengha mengharap rapkan kan kritik kritik dan saran saran yang yang sifatn sifatnya ya memban membangun gun demi demi  perbaikan di masa mendatang. Akhirnya saya berharap semoga laporan ini bermanfaat bagi saya pribadi, maupun adik kelas, pembaca dan dunia pendidikan.

Jakarta, November 2007 Penyusun,

(Zeffa Aprilasani)

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DAFTAR ISI

Lembar persetujuan ............................................ ................................................................... ....................................... ................ Lembar pengesahan ............................................ ................................................................... ....................................... ................ Kata pengantar.. pengantar....... .......... .......... .......... .......... .......... .......... .......... .......... ......... ......... .......... .......... .......... .......... .......... .......... .......... .......

i

Daftar isi....... isi............ .......... ......... ......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ......... ......... .......... .......

iii

Daftar gambar..... gambar.......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ......... ......... .......... .......... .......... .......... .......... .......

v

Daftar tabel....... tabel............ .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ......... ......... .......... ........ ...

v

Daftar Lampiran... Lampiran........ .......... .......... .......... ......... ......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .....

v

Bab I Pendahuluan I.1.Latar I.1.Latar Belakang Belakang Prakerin... Prakerin........ .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ........…. ...…... 1 I.2.Tujuan I.2.Tujuan Prakerin.. Prakerin....... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ........ ... 2 I.3.Tujuan Analisis Bahan........................................... Bahan.................................................................. ................................. .......... 2 I.4.Tujuan I.4.Tujuan Penulisan Penulisan Laporan... Laporan........ .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ......…. .…. 2

Bab II Insitusi Perusahaan II.1. Sejarah Singkat Singkat Perusahaan Perusahaan .......... ............... .......... .......... .......... .......... .......... .......... ......... ......... .......... .......... ..... 3 II.2. Struktur Organisa Organisasi si Perusahaan Perusahaan..... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ........ ...

6

II.3. Administrasi Laboratorium.................................... Laboratorium............................................................ .............................. ...... 9 II.4. Jenis Produk.................................. Produk......................................................... .............................................. ................................ ......... 16

Bab III Tinjuan Pustaka III.1. Obat...... Obat........... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ........ ...

17

III.2. Proses Proses Produksi Produksi Sediaan Kaplet..... Kaplet.......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......

20

III.3. Deskripsi Pengelompokan Komoditas................................... Komoditas............................................... ............ 23 III.4. Uraian Tentang Tentang Parasetamol. Parasetamol...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ....... 25

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Bab IV. Bahan dan Metode IV.1. Penetapan Penetapan Kadar Parasetamol Parasetamol Menggunakan Menggunakan Spektrofotomet Spektrofotometer... er........ ..... 37 IV.2. Penetapan Penetapan Kadar Kadar Parasetamol Parasetamol dengan dengan Uji Disolus Disolusi.... i......... .......... .......... .......... ....... ..

39

IV.3. Penetapan Uji Fisika Produk Parasetamol................... Parasetamol.......................................... ....................... 41

Bab V Hasil dan Pembahasan V.1. Hasil...... Hasil........... .......... .......... .......... .......... .......... .......... .......... .......... ......... ......... .......... .......... .......... .......... .......... .......... .......... ......... ....

44

V.2. Pembahasan Pembahasan..... .......... ......... ......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ......... ....

46

Bab VI. Kesimpulan dan saran VI.1. Kesimpulan...................... Kesimpulan.............................................. ............................................... ............................................ ..................... 47 VI.2. Saran............................................. Saran.................................................................... .............................................. ................................ ......... 48

Daftar Pustaka...................................... Pustaka............................................................. .............................................. ................................... ............ 49

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DAFTAR GAMBAR 

Gambar III.1. Proses Waste Water Treatment Plant  (W (WWT WTP) P).. .... .... .... .... .... .... .... .... ..

15

Gambar Gambar III.2. Struktur Kimia Parasetamol... Parasetamol........ .......... .......... .......... .......... .......... .......... .......... .......... ....... 25 Gambar Gambar III.3. III.3. Diagram Diagram Kotak Kotak Spektro Spektrofotom fotometer... eter........ ......... ......... .......... .......... .......... .......... ....... ..

30

Gambar Gambar III.4. Dispersi Dispersi cahaya cahaya oleh prisma..... prisma.......... .......... .......... .......... .......... .......... .......... .......... ........ ...

31

Gambar III.5. Skema Spektrofotometer  single ......... ...... ...... ...... ...... ...... ...... ...... ...... ...  single beam ......

33

DAFTAR TABEL

Tabel 5.1.

Hasil Penetapan Kadar Parasetamol Menggunaka Menggunakan n Spektrofoto Spektrofotometer.. meter....... .......... .......... .......... .......... .......... .......... .......... ....... .. 44

Tabel Tabel 5.2. 5.2.

Hasil Hasil Peneta Penetapan pan Kadar Kadar Parase Parasetam tamol ol dengan dengan Uji Disolu Disolusi. si.... ..... ..

45

Tabel Tabel 5.3. 5.3.

Hasil Hasil analis analisis is Penetap Penetapan an Uji Fisika Fisika Produk Produk Parase Parasetam tamol. ol.... ...... .....

46

DAFTAR LAMPIRAN

Lamp Lampira iran n 1.

Stru Strukt ktur ur Orga Organi nisa sasi si Glax GlaxoS oSmi mith thKl Klin inee Indo Indone nesi siaa .... ...... .... .... .... ....

50

Lampir Lampiran an 2 . Denah Denah Loka Lokasi si Glax GlaxoSm oSmith ithKli Kline ne Indon Indonesi esia.. a..... ...... ...... ...... ...... ...... ...... ...... ...

51

Lampiran Lampiran 3. 3. Alur Bahan Bahan Baku.. Baku....... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ....... .. 52 Lampiran Lampiran 4. 4. Alur Produk Produk Ruahan Ruahan Sediaan Sediaan Kaplet... Kaplet....... ......... .......... .......... .......... .......... .......... ....... .. 53 Lampiran Lampiran 5. Alur Produk Produk Ruahan Ruahan Yang Ditolak.... Ditolak......... .......... .......... .......... .......... .......... .......... ........ ... 54 Lampiran 6. Data Hasil Penetapan Kadar Parasetamol Parasetamol Menggunakan Menggunakan Spektrofot Spektrofotometer ometer UV Visible.... Visible......... .......... ......... ......... .......... .......... .......... .......... .......... ....... .. 55 Lampiran 7. Data Hasil Hasil Penetapan Penetapan Kadar Parasetamol dengan dengan Uji Disolusi Disolusi (Mengg (Menggunak unakan an Spektrofo Spektrofotomete tometerr UV Visible)... Visible)... 56 Lampiran 8. Gambar Basket pada Alat Disolusi..................................... Disolusi.......................................... ..... 57 Lampiran 9. Gambar Dayung pada Alat Disolusi Disolusi ....................................... 58 Lampiran 10. Gambar Gambar Alat Spektrofotometer UV Visible Shimadzu 1601... 59 Lampiran Lampiran 11. Gambar Alat Disolusi Disolusi SR-8 plus plus Hanson Research.. Research....... .......... .......... ..... 60 Lampiran 12. Gambar Alat Gambar  Alat Uji Fisika.... Fisika......... .......... .......... .......... ......... ......... .......... .......... .......... .......... .......... ....... .. 61 Lampiran Lampiran 13. Gambar Gambar Neraca Neraca Analitik Analitik Mettler Toledo Toledo XS 205.... 205......... .......... .......... ....... 62

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BAB I PENDAHULUAN

I.1. Latar Belakang Prakerin

Pengetahuan dan keterampilan yang menjurus pada satu bidang pekerjaan yang diperoleh melalui pendidikan kejuruan, secara khusus memerlukan media yang bersifat melatih penerapannya dan memperjelas fungsi yang sebenarnya. Hal ini berkaitan dengan tuntutan tuntutan agar secara langsung langsung dapat menerapkan menerapkan teori-teori dan dan prak prakti tik-p k-prak rakti tik k yang yang tela telah h diku dikuas asai ai seba sebaga gaii peng penget etah ahua uan n yang yang dapa dapatt   berma bermanfa nfaat at bagi bagi orang orang banyak banyak.. Penget Pengetahu ahuan an dan keteram keterampil pilan an analis analis kimia kimia merupakan salah satu bidang ilmu yang pendidikannya memerlukan pendekatan  pada fungsi sesungguhnya di tengah masyarakat. Media yang diprogramkan untuk  hal tersebut adalah Praktik Kerja Industri (PRAKERIN). Pelaksanaan Prakerin tidak tidak terbatas terbatas pada pada prakti praktik k labora laborator torium ium saja saja tetapi tetapi juga juga prakti praktik k pengen pengenala alan n lingkungan kerja yang sesungguhnya. Pada Pada kesemp kesempata atan n ini, ini, Judul Judul yang yang dipero diperoleh leh penuli penuliss adalah adalah “Penet “Penetapa apan n Kad Kadar

Para Parase seta tamo moll

dalam alam

Sedi Sediaa aan n

Kapl Kaplet et”. ”.

Dala Dalam m

prose rosess

prod produk uksi si

memungkinkan terjadinya kesalahan, sehingga perlu dilakukan analisa terhadap   produk ruahan. Atas dasar itulah, dilakukan analisis kadar Parasetamol dalam   produk produk ruahan yang bertujuan bertujuan untuk untuk menyesuaik menyesuaikan an kadar Parasetamol dalam  produk dengan limit kadar yang telah ditetapkan oleh QA Departement. Sehingga dapat diketahui apakah produk ruahan tersebut dapat diproses lebih lanjut menjadi  produk jadi atau tidak.

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3. Mening Meningkat katkan kan wawasa wawasan n siswa siswa pada pada aspek aspek profes profesion ional al dalam dalam dunia dunia kerja kerja antara lain struktur organisasi, disiplin, disiplin, lingkungan kerja, dan sistem kerja. 4. Menin Meningk gkat atka kan n peng penget etah ahua uan n sisw siswaa dala dalam m hal hal tekno teknolo logi gi baru baru khus khusus usny nyaa  penggunaan instrumen kimia analisis yang modern, dibandingkan dengan fasilitas yang tersedia di sekolah. 5. Member Memberika ikan n kesemp kesempata atan n kepada kepada siswa siswa untuk untuk membia membiasak sakan an diri diri dengan dengan suasana kerja yang sebenarnya. 6. Memperkenal Memperkenalkan kan fungsi dan tugas tugas analis kimia kepada kepada lembaga-lembaga lembaga-lembaga  penelitian dan perusahaan industri serta memberikan peluang penempatan dan meningkatkan kerjasama antara sekolah dengan institusi perusahaan. I.3. Tujuan Analisis Bahan

Analisa yang dilakukan terhadap produk bertujuan untuk: 1. Agar Agar siswa siswa praker prakerin in dapat dapat mengan menganalis alisaa kandun kandungan gan zat aktif aktif Parase Parasetam tamol ol dala dalam m prod produk uk Para Parase seta tamo moll sedi sediaa aan n kapl kaplet et sesu sesuai ai deng dengan an meto metode de dan dan spesifikasi yang ditetapkan perusahaan. 2. Melindungi konsumen konsumen dari bahaya over dosis dosis dan keracunan keracunan obat. 3. Menyes Menyesuai uaikan kan kadar kadar Parase Parasetam tamol ol yang yang di analis analisis is dengan dengan limit limit yang yang di tetapkan, baik oleh BPOM maupun oleh QA Departement sehingga dapat diketahui apakah produk yang di produksi layak dipasarkan. I.4. Tujuan Penulisan Laporan

Hasil pelaksanaan Praktik Kerja Industri dituangkan dalam bentuk laporan yang tujuannya adalah : 1. Memant Memantapk apkan an siswa siswa dalam dalam memaha memahami mi dan mengem mengemban bangka gkan n ilmu ilmu yang yang

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BAB II INSTITUSI PERUSAHAAN

II.1. Sejarah Singkat Perusahaan

GlaxoSmithKline (GSK) merupakan perusahaan multinasional yang berbasis   pada pada riset riset yang yang memili memiliki ki keung keunggul gulan an dibida dibidang ng peneli penelitian tian,, pengem pengemban bangan gan,, kekuat kekuatan an pemasa pemasaran ran,, dan keuang keuangan. an. Selain Selain itu, itu, GlaxoSm GlaxoSmith ithklin klinee adalah adalah satusatusatu satuny nyaa peru perusa saha haan an farm farmas asii yang yang meng mengat atas asii tiga tiga peny penyak akit it utam utamaa yang yang di identifikasi oleh World Health Organization Organization , yaitu HIV/AIDS, Tuberculosis, dan malaria. malaria. GlaxoSmith GlaxoSmithkline kline terdapat di 117 negara dengan dengan jumlah jumlah karyawan karyawan lebih dari dari 100,00 100,000 0 jiwa. jiwa. Dan lebih lebih dari dari 15,000 15,000 jiwa jiwa tim peneli peneliti. ti. GlaxoSm GlaxoSmith ithkli kline ne memoni memonitor toring ing lebih lebih dari dari 65 juta juta senyaw senyawaa setiap setiap tahun tahun dalam dalam peneli penelitia tianny nnyaa terhadap terhadap obat obat baru. baru. Dan mempro memproduks duksii hampir hampir 4 milyar milyar pack obat-ob obat-obatan atan dan dan   produ produk k keseha kesehatan tan.. Serta Serta mensup mensuplai lai sepere seperempa mpatt dari dari vaksin vaksin di seluru seluruh h dunia. dunia. Terdapat beberapa produk yang menjadi unggulan dalam keberhasilan program  pemasaran GlaxoSmithKline. Yaitu empat diantara lima kelas terapeutik utama di dunia ; anti infeksi, Susunan Saraf Pusat/SSP (Central Nervous System, CNS), salu saluran ran nafa nafass (resp (respira irato tory ry), ), dan dan salu salura ran n cerna cerna (gas (gastr troi oint ntes esti tina nal) l),, sela selain in itu itu didukung pula oleh keberhasilan produk vaksin, dan beberapa produk dibidang  perawatan oral seperti perawatan gigi serta minuman kesehatan bernutrisi. GlaxoSmithKline merupakan gabungan 2 perusahaan farmasi yaitu Glaxo Wellcome dan SmithKline Beecham. Masing-masing perusahaan memiliki sejarah

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( Beecham pada akhirn akhirnya ya menemu menemukan kan antibi antibioti otik  k    Beecham Research Research Laborato Laboratories ries), dan pada

amoxilin dan augmentin . Demi meningkatkan efisiensi kerja, pada tanggal 26 juli 1989 dilakukan penggabungan antara SmithKline Beecham dan Beecham Group menjad menjadii Smithk Smithklin linee Beecha Beecham, m, kemudi kemudian an SmithK SmithKlin linee Beecha Beecham m mengak mengakusi usisi si Sterling Health. Glaxo Wellcome sebelumnya terdiri dari gabungan 2 perusahaan besar, yaitu yaitu Glaxo Glaxo dan Burrou Burroughs ghs Wellco Wellcome. me. Glaxo Glaxo berasa berasall dari dari produk produksi si susu susu dan mentega, mentega, yang kemudian kemudian berkembang berkembang dengan dengan ditemukanny ditemukannyaa  streptomycin dan vitamin B12. Sementara Burroughs Wellcome terbentuk pada tahun 1818, terkenal dengan dengan produknya produknya digoxin dan  polymixin . Tahun Tahun 1995 1995 Glaxo Glaxo dan Burrou Burrough ghss  bergabung menjadi Glaxo Wellcome.

Penggabungan Glaxo Wellcome dan SmithKline Beecham terjadi pada tanggal 27 Desember 2000 menjadi GlaxoSmithKline, sedangkan di Indonesia  baru dilakukan pada tanggal 8 Januari 2001. GlaxoSmithKline secara  Legal Entity masi masih h terd terdap apat at di 3 peru perusa saha haan an,, yait yaitu u PT. PT. Sterl Sterlin ing g Prod Produc uctt Indo Indone nesi sia, a, PT. PT. SmithKline Beecham, dan PT. Glaxo Wellcome Indonesia. Penulis melaksanakan  prakerin di PT. Sterling Product Indonesia. II.1.1. Logo Perusahaan

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Misi : Meningkatkan kualitas hidup manusia dengan memberdayakan manusia

agar dapat berbuat lebih banyak, merasa lebih baik, dan hidup lebih lama. Mengejar ar tujuan tujuan dengan dengan semang semangat at kewiras kewiraswas wastaan taan,, dan selalu selalu Semang Semangat at : Mengej  berinovasi serta menghargai kinerja yang dicapai dengan integritas. II.1.3. Lokasi dan Tata Letak Perusahaan

Lokasi GlaxoSmithKline, dimana penulis melaksanakan prakerin adalah di Cimanggis (GlaxoSmithKline site Bogor), Jalan Raya Bogor KM 35. Perusahaan ini memiliki luas tanah sebesar 19460 m 2 dengan luas keseluruhan bangunan 3302 m 2, terbagi menjadi dua plant, yaitu  plant antibiotik dan plant nonantibiotik. Marketing GlaxoSmithKline tidak berada satu kompleks dengan perusahaan. Namun berada di Graha Paramita lantai 5, Jalan Denpasar Denpasar Raya Blok D-2 Kuningan, Kuningan, Jakarta. II.1.4. Kepegawaian

Karyawan di GlaxoSmithKline terdiri dari karyawan tetap dan karyawan kontrak. Perusahaan ini beroperasi dari senin sampai jumat, dengan  jadwal kerja terbagi menjadi tiga shift, yaitu : - Shif Shiftt 1

: puku ukul 07.3 07.300-16 16.0 .00 0

- Shif Shiftt II

: puku pukull 15.3 15.300-23 23.0 .00 0

Shift III

pukul 22.30-06.30

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Adapun disiplin kerja bagi seluruh pekerja adalah sebagai berikut : 1. Pekerja Pekerja wajib wajib menaati menaati dan melaksanakan melaksanakan jam kerja yang telah ditentukan ditentukan deng engan menca encata tatk tkan an diri diri pada ada wakt waktu u jam jam masuk asuk kerj kerjaa dan saat aat meninggalkan pekerjaan. 2. Pekerja Pekerja yang terlamb terlambat at masuk kerja karena karena alasan alasan yang sah, harus harus melapor  melapor  kepada atasan langsung atas keterlambatan itu. 3. Peker ekerja ja dihar iharus uska kan n mema memak kai tand tandaa pen pengena genall pegaw egawai ai yang ang tela telah h dikeluarkan oleh perusahaan.

Pekerja yang ingin meninggalkan pekerjaan lebih cepat dari pada biasanya karena hal-hal yang mendesak, harus mendapat ijin tertulis terlebih dahulu dari atasannya langsung dan diketahui oleh kepala departemen. Sela Selain in

itu, itu,

Glax GlaxoS oSmi mith thKl Klin inee

pun pun

memp memper erha hatik tikan an

kese keseja jaht hter eraan aan

kary karyaw awan anny nyaa dala dalam m bent bentuk uk fasil fasilit itas as dan dan jami jamina nan n sosi sosial al yang yang dibe diberik rikan an.. Keseja Kesejahte hteraan raan tersebu tersebutt didasa didasari ri atas atas kerjas kerjasama ama antara antara serika serikatt pekerja pekerja dengan dengan  perusahaan yang diatur dalam Kesepakatan Kerja Bersama (KKB). KKB berisi tentang jaminan bagi serikat pekerja, aturan kerja, aturan penggajian, jaminan

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  beserta beserta tugas dan wewenangny wewenangnya. a. Struktur Struktur organisasi organisasi GlaxoSmithKlin GlaxoSmithKlinee dapat dilihat pada Lampiran I.1. Pimpinan puncak perusahaan di Indonesia dipegang oleh seorang tehnical director yang dibantu oleh tiga orang manajer, yaitu Pulogadung Site Quality Manager, Compliance Manager, Bogor Site Manager. Bentuk organisasi ini adalah gabungan dari struktur organisasi garis dan fungs fungsion ional. al. Wewena Wewenang ng langsu langsung ng didele didelegas gasii dari dari atas atas ke bawah, bawah, sedang sedangkan kan tanggung jawab mengalir dari bawah ke atas. II.2.1. Quality Assurance Department

Qualit Quality y Assura Assurance nce Departm Department ent dipimp dipimpin in oleh oleh   Head Head of Quali Quality ty dan membawahi QA Manager Pulogadung, QA Manager Compliance, dan QA Manager Manager Bogor. Bogor. Struktur Struktur organisasi organisasi dalam QA/QC beserta tugasnya, meliputi : a. QA/QC Koordinator - Mengatur agar kegiatan di QA/QC berjalan lancar.

- Melaporkan kepada QA/QC Manager apabila menemukan kelainan-kelainan

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b. QA/QC Sekretaris

- Memb Membua uatt tren trend d data data semu semuaa baha bahan n baku baku (raw material  ) , baha bahan n kema kemass material ), (  packaging ), dan bara barang ng jad jadi (  finishe Sertaa memb membua uatt packaging material  finished d goods goods). Sert

Certifikat of Analist . - Melakukan pengetikan form-form yang terkait dengan analisa. - Mengurus dan mendata absent QA/QC. - Membuat surat-menyurat keperluan QA/QC dan menghubungi  supplier  serta relasi. - Bertanggung jawab terhadap dokumentasi training , memelihara form training  dan membuat rangkuman setiap training . c. QA/QC Technician (Analis)

- Melakukan analisa bahan baku. - Melakukan analisa produk setengah jadi dan produk jadi. - Melakukan kegiatan validasi. - Mengontrol validasi reference standard.

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- Membantu QA/QC Technician dalam preparasi reagen maupun analisa, bila diperlukan. - Menjaga ruangan QA/QC tetap bersih. II.3. Administrasi Laboratorium

Quality Quality Assurance Assurance merupakan bagian yang bertugas menjamin bahwa  produk yang dihasilkan memenuhi persyaratan mutu yang sesuai dengan tujuan  penggunaannya sebelum produk tersebut dipasarkan ke masyarakat luas. Ruang Ruang lingku lingkup p QA melipu meliputi ti semua semua fungsi fungsi analis analisis is yang yang dilaku dilakukan kan di laboratorium. Bagian QA memiliki laboratorium terpisah dari ruang produksi. Dan dirancang sedemikian rupa sehingga antara laboratorium kimia, fisika, dan mikrobiologi terpisah satu sama lain. Masing-masing laboratorium memiliki pengukur suhu berupa chart satu arah. Semua peralatan di QA digunakan untuk pengukuran, dan dikalibrasi sesuai   jadwal yang ditetapkan. Semua analisis yang dilakukan di QA harus terdaftar  dalam catatan analisis yang telah disediakan. Bahan dan reagen ditempatkan berdasarkan sifatnya, yaitu asam, basa, dan mudah udah terb terbak akar ar sert sertaa koro korosi sif. f. Reag Reagen en yan yang dib dibuat, uat, dib diberi eri labe labell yang ang

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- Menjamin bahwa produk GSK adalah paten.

II.3.1. Validasi

Proses validasi adalah suatu tindakan pembuktian dengan cara yang sesuai   bah bahwa wa tiap tiap baha bahan, n, pros proses es,, pros prosed edur ur,, kegi kegiat atan an,, sist sistem em,, perl perlen engk gkap apan an,, atau atau mekanisme mekanisme yang digunakan digunakan dalam produksi produksi dan pengawasan pengawasan akan senantiasa senantiasa mencapai hasil yang diinginkan. Valida Validasi si melipu meliputi ti valida validasi si proses proses,, valida validasi si prosed prosedur ur pemerik pemeriksaa saan n dan validasi pembersihan. Validasi Proses Vali Valida dasi si

Pros Proses es

adal adalah ah

cara cara

pema pemast stia ian n

dan dan

memb member erii

pemb pembuk ukti tian an

terdokumentasi bahwa proses (berlangsung dalam parameter desain yang telah ditentukan) mampu dan dapat dipercaya menghasilkan produk yang sesuai dengan kualitas yang diinginkan dan memiliki tingkat keberulangan yang tinggi.

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Pres Presis isii adal adalah ah kede kedeka kata tan n bebe beberap rapaa nilai nilai peng penguk ukur uran an seri seri samp sampel el yang yang homogen pada kondisi normal (sampel yang sama dan diuji secara   berur beruruta utan), n), dan penent penentuan uan presis presisii ini pada pada umumny umumnyaa mencak mencakup up  pemeriksaan: a. Repeatibility yang dinyatakan sebagai hasil presisi dibawah perlakuan yang sama (analisa dan alat yang sama) dalam interval waktu pemeriksaan yang singkat.  b.  Intermediate  Intermediate precision yang dilakukan dengan cara mengulang pemeriksaan tersebut dengan menggunakan alat yang berbeda, hari yang berbeda,analis yang berbeda dan sebagainya. c.  Reproducibility yang dinyatakan sebagai presisi yang diperoleh dari hasil  pengukuran pada laboratorium yang berbeda.

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member memberika ikan n respon respon yang yang signif signifika ikan n diband dibanding ingkan kan blanko blanko tanpa tanpa adanya pengaruh dari alat.

Limit Kuantitas Limit Limit Kuanti Kuantitas tas adalah adalah konsen konsentra trasi si analit analit yang yang dapat dapat ditetap ditetapkan kan dengan dengan  presisi/repeatibilitas yang masih dapat diterima pada kondisi pengujian tertentu. Limit kuantitas adalah parameter penetapan kadar untuk konsentrasi terendah dari   bangunan bangunan matrik contoh contoh dan biasanya biasanya digunakan digunakan untuk menentukan menentukan impurity impurity  bagi produk yang tidak bagus.

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 Robustness adalah ah ukur ukuran an kema kemamp mpua uan n  Robustness adal

meto metode de anal analis isis is untu untuk k

tida tidak  k 

terpen terpengar garuh uh oleh oleh peruba perubahan han kecil, kecil, seperti seperti varias variasii yang yang sengaj sengajaa dibuat dibuat dalam dalam  parameter metode analisis. Serta dapat memberikan indikasi kehandalannya dalam  penggunaan secara normal. Validasi Pembersihan Valid Validas asii pemb pember ersi siha han n untu untuk k pera perala lata tan n perl perlu u dilak dilakuk ukan an kare karena na pros proses es   pembersihan peralatan harus segera dilaksanakan setelah suatu produk selesai dibuat atau dikemas. Validasi pembersihan bertujuan untuk memastikan bahwa   pro prose sedu durr pemb pember ersi siha han n suda sudah h tepa tepatt dan dan efekt efektif if meng menghi hilan langk gkan an sisa sisa prod produk  uk  sebelumnya (termasuk melihat cemaran mikroba). Agar mendapatkan peralatan

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anta antara ra lain lain deng dengan an kegi kegiata atan n iden identi tifi fika kasi si,, regu regulas lasii dan dan peng pengol olah ahan an limb limbah ah,, misalnya sistem Waste Water Treatment Plant  (WWTP) untuk pengolahan limbah cair cair (Gamba (Gambarr II.1.) II.1.).. Dari Dari segi segi healthy monitoring  dilakukan dilakukan terhadap terhadap seluruh seluruh kary karyaw awan an maup maupun un peng pengun unju jung ng yait yaitu u deng dengan an pema pemant ntau auan an pero peroran ranga gan n dan dan  pemantauan  pemantauan lingkungan, lingkungan, sedangkan sedangkan dari segi  safet y diwujudkan dalam program   peny penyusu usunan nan prosed prosedur ur dan cara kerja kerja yang yang aman, aman, antisi antisipas pasii terhad terhadap ap keadaa keadaan n darurat dan kecelakaan, serta adanya MSDS ( Material Safety Data Sheet ) untuk  semua bahan kimia yang digunakan dalam kegiatan industri. Dilihat dari sisi EHS khususnya environmental , salah satu hal yang perlu diperhatik diperhatikan an adalah penanganan penanganan limbah. limbah. Limbah Limbah GlaxoSmith GlaxoSmithKline Kline dibedakan dibedakan menjadi dua macam yaitu : 1. Limbah Limbah Domest Domestik ik adalah adalah limbah limbah hasil hasil kegiatan kegiatan kantin kantin MCk, MCk, dan fasilitas fasilitas

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Limbah B3 cair dialirkan melalui saluran drainage khusus ke WWTP dan dikemas dalam kemasan yang tidak mudah pecah dan bocor dan diangkut ke PPLI a.

Limbah

B3 B3

padat

di dikumpulkan

kemasa kemasan n yang tidak mudah mudah pecah dan bocor, bocor, diperiks diperiksaa

da dalam

dan dihitu dihitung ng

  juml jumlah ahny nya, a, catat catat dala dalam m cata catatan tan peng pengol olah ahan an batc batch h untu untuk k baha bahan n sisa sisa   pen pengo gola laha han, n, seda sedang ngka kan n sisa sisa baha bahan n peng pengem emas as ditu dituli liss dala dalam m catat catatan an  pengemasan batch, untuk selanjutnya diangkut ke PPLI.

Penyimpanan limbah dilakukan seperti diatur dalam PP No 18 tahun 1999 tentang pengolahan B3 paling lama 90 hari sebelum diserahkan pada perusahaan  pengolah dan penimbun limbah B3 yang ditunjuk dalam hal ini PPLI (Prasada

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Cek Laboratorium (monitoring)

Dibuang ke saluran pembuangan

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 b). Eliksir  Eliksir adalah suatu larutan alkoholis yang diberi pemanis mengandung obat dan diberi bahan pembahu. Sebagai pelarut adalah gliserin, sirup, atau larutan sorbitol.

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d). Suppositoria Suppositori Suppositoriaa merupakan merupakan suatu suatu bentuk bentuk sediaan sediaan padat yang pemakaiann pemakaiannya ya dengan dengan cara memasu memasukka kkan n melalu melaluii lubang lubang atau celah celah pada pada tubuh, tubuh, dimana dimana sediaan akan melebur, melunak, dan memberikan efek lokal atau sistemik.

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