LAPORAN INDUSTRI

K FARMASI
E L O M P O K 1

AMALIA NUR K
AYUNI
DIMAS MAULANA
NADISA NUR KHOLIZA
NURUL HIKMAH
PUTRI SEPTIANDARI
 BAB I
PENDAHULU
AN
You could enter a subtitle here if you need
it
 Tujuan

Tujuan PKL Tujuan Pembuatan

Laporan
BAB II
ISI
 1. Uraian Umum
Pengertian Industri Farmasi
Berdasarkan Peraturan Badan Pengawas Obat
dan Makanan Nomor 34 Tahun 2018 tentang
Pedoman Cara Pembuatan Obat yang Baik ,
yang dimaksud dengan industri farmasi adalah
badan usaha yang memiliki izin sesuai dengan
ketentuan peraturan perundang-undangan
untuk melakukan kegiatan pembuatan obat
atau bahan obat.
Cara Pembuatan Obat yang Baik
(CPOB)
Menurut Peraturan Badan Pegawas Obat dan
Makanan Nomor 34 Tahun 2018 tentang Pedoman
Cara Pembuatan Obat yang Baik (CPOB), CPOB
adalah bagian dari Manajemen Mutu yang memastikan
obat dibuat dan dikendalikan secara konsisten untuk
mencapai standar mutu yang sesuai dengan tujuan
penggunaan dan persyaratan Izin Edar, Persetujuan Uji
Klinik atau spesifikasi produk. CPOB mencakup
produksi dan pengawasan Mutu.
 Personalia
Industri farmasi harus bertanggung jawab untuk menyediakan personel yang
terkualifikasi dalam jumlah yang memadai untuk melaksanakan semua tugas.
Tanggung jawab individual secara jelas dipahami oleh masing-masing dan
didokumentasikan. Seluruh personel hendaklah memahami prinsip CPOB yang

Banguna menyangkut tugasnya serta memperoleh pelatihan awal dan berkesinambungan,

termasuk instruksi higiene yang berkaitan dengan pekerjaannya.

n
Bangunan untuk pembuatan obat
memiliki ukuran, rancang bangun,
konstruksi, serta letak yang memadai
Produksi
Produksi hendaklah dilaksanakan dengan
mengikuti prosedur yang telah ditetapkan,
agar memudahkan dalam pelaksanaan
dan memenuhi ketentuan CPOB yang
kerja, pelaksanaan kebersihan, dan
menjamin senantiasa menghasilkan produk
pemeliharaan yang baik. Lokasi
yang memenuhi ketentuan izin pembuatan
bangunan hendaklah dipilih lokasi yang
dan izin edar (registrasi). Mutu suatu obat
bebas dari pencemaran lingkungan.
tidak hanya ditentukan oleh hasil analisa
Selain itu bangunan mempunyai ventilasi
terhadap produk akhir melainkan juga oleh
udara yang baik, serta sistem pengolahan
mutu yang dibangun selama tahapan
limbah, serta menghindari terjadinya
proses produksi sejak pemilihan bahan
pencemaran silang dan terlewatnya
awal, penimbangan, proses produksi
prosedur produksi yang dapat
personalia sampai dengan pengemasan.
menurunkan mutu obat.
Pengawasan Mutu Penarikan Dokumentasi
Bagian yang esensial dari cara Kembali Obat Jadi Bagian dari sistem
pembuatan obat yang baik proses penarikan kembali obat dari informasi manajemen
untuk memastikan tiap obat semua mata rantai distribusi bila dan dokumentasi yang
yang dibuat senantiasa ditemukan adanya cacat kualitas dan baik merupakan bagian
memenuhi persyaratan mutu yang berbahaya, atau dilaporkan yang esensial dari
yang sesuai adanya reaksi merugikan yang Pemastian Mutu
membahayakan kesehatan
pemakainya selama atau sesudah
pendistribusian obat jadi tersebut
 Inspeksi
Diri
Untuk mengevaluasi apakah semua aspek poduksi dan
pengawasan mutu industri farmasi memenuhi
ketentuan CPOB. Program Inspeksi Diri hendaklah
dirancang untuk mendeteksi kelemahan dalam
pelaksanaan CPOB dan untuk menetapkan tindakan
perbaikan yang diperlukan.
 2. Uraian Khusus
Sejarah Content 1

LAFI Content 2

Content 3

AU Content 4

Struktur Content 5

Content 6
Organisasi
 Produksi

Sefalosforin

Non Beta
Beta Laktam
Laktam
 Gudang Pemastian
Mutu (QA)

Uraian
Pengawasan
Mutu (QC) Khusu Pengelolaan
Limbah
s
Bagian Penelitian Tugas dan
dan Kewenangan
Pengembangan Asisten Apoteker di
( RnD) Industri
“ BAB III
PEMBAHASAN
 Produksi

01 02 03 04 Pengawasan Bagian Penelitian Enrollment

Gudang Mutu ( QC ) dan
Process
Here you could Here you could
Pengembangan Here you could
describe the topic describe the topic (RnD) describe the topic
of the section of the section of the section
Here you could
describe the topic
of the section
“
This is a quote. Words full of wisdom
that someone important said and can
make the reader get inspired.”
—Someone Famous
 Our Teaching Method

Feedback &
Evaluation
Saturn is composed
Activities mostly of hydrogen Goals
and helium
Despite being red, Jupiter is a gas giant
Mars is a cold place full and the biggest planet
of iron oxide dust in the Solar System
 Mercury Neptune Mars
Despite being red, Mars Neptune is the fourth- Jupiter is a gas giant
is actually a cold place largest planet in the and the biggest planet
full of iron oxide dust Solar System in the Solar System
 The Curriculum
Content 1

60
Initial
Content 2

%
Content 3

Content 4

40
Advanced Content 5

Content 6

%
 Academic Areas

Mars Venus Mercury

Mars is actually a Venus is the second It’s the closest
cold place planet from the Sun planet to the Sun

Jupiter Saturn Neptune

It’s the biggest Saturn is a gas giant It’s the farthest
planet of them all and has rings planet from the Sun
 Our Values

Loyalty Efficiency
Mercury is a bit larger Despite being red, Mars
than the Moon is actually a cold place

Reliability Commitment
Venus is the second Neptune the farthest
planet from the Sun planet from the Sun
A Picture
Is Worth
a
Thousan
d Words
4,000,300
Big numbers catch your audience’s attention
Students Around the World

This is a map where

you can mark the size
of your audience

Jupiter is the biggest

planet in the Solar
System and the
fourth-brightest
object in the night sky
 Our Teachers

John James Jenna Doe Jane Patt

You can talk about You can talk about You can talk about
the actions here the actions here the actions here
 Saturn Mars
It has several rings It’s a cold place

Jupiter Our Neptune

It’s the biggest one
Goals It’s the farthest one

Venus Pluto
It’s quite hot It’s a dwarf planet
 Student Process

1st Term 2nd Term 3rd Term 4th Term

Mercury is the Jupiter is the Despite being red, Saturn is a gas giant
smallest planet biggest planet Mars is a cold place and has rings
 Enrollment Process
You could state one of your
1st Process enrollment processes here

You could state one of your

2nd Process enrollment processes here

You could state one of your

3rd Process enrollment processes here

You could state one of your

4th Process enrollment processes here
Special Reminders

● Saturn is composed of
hydrogen and helium
● Jupiter is the biggest
planet of them all
● Despite being red,
Mars is a cold place
● Mercury is the closest
planet to the Sun
 Thanks
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