INDUSTRI

FARMASI
Pengertian
• Peraturan Menteri Kesehatan Republik
Indonesia Nomor 1799/MENKES/PER/XII/2010:
 “Industri farmasi adalah badan usaha yang
memiliki izin dari Menteri Kesehatan untuk
melakukan kegiatan pembuatan obat atau
bahan obat.”
 Industri farmasi dapat melakukan kegiatan
proses pembuatan obat dan atau bahan obat
untuk semua tahapan dan atau sebagian
tahapan.
Pendirian Industri Farmasi
 Aspek Legal/Administratif:
 Ijin prinsip  ijin pendirian usaha
 RIP  Rencana Induk Pembangunan
 Sertifikasi CPOB
 Aspek Fisik:
 Bangunan
 Sarana Penunjang
 SDM
Izin Industri
 Setiap pendirian industri farmasi wajib memperoleh izin
industri farmasi dari Direktur Jendral Pembinaan
Kefarmasian dan Alat Kesehatan Menteri Kesehatan RI
 Persyaratan:
 berbadan usaha berupa perseroan terbatas
 memiliki rencana investasi dan kegiatan pembuatan obat
 mimiliki NPWP
 memilki secara tetap paling sedikit 3 (tiga) orang Apoteker
 komisaris dan direksi tidak pernah terlibat, baik langsung atau
tidak langsung dalam pelanggaran peraturan perundang–
undangan di bidang kefarmasian.
Sertifikasi CPOB
 Bukti kepatuhan IF terhadap CPOB
 Berlaku selama 5 tahun
 Sertifikasi per bentuk sediaan
 Diperoleh dengan cara:
 Menerapkan CPOB
 Permohonan Sertifikasi
 Audit Sertifikasi
 CAPA
Prinsip Dasar
Important aspects to be kept in mind to ensure the
suitability of the operations to be carried out for different
dosage forms and product range:
 Location
 Design
 Construction
 Adaptation
 Maintenance
LOCATION
 Geography, climate, noise and economic factors
 Neighbours
 What do they do?
 What impact can they have on the
business?
 Pollution/effluent control
 Minimum risk for contamination of products and materials
 Location
 Bangunan industri
farmasi harus
berada di lokasi
yang bisa
menimalkan
cemaran. Misal:
jauh dari lokasi
pembuangan
sampah, pabrik
malting (peragian)
 Jauh dari TPA
DESIGN Layout
Layout dan design bangunan IF harus bertujuan untuk:
 Minimize risks of errors
 Memungkinkan effective cleaning dan disinfeksi sesuai
dengan SPO
 Memungkinkan effective maintenance
 Menghindarkan cross-contamination, penumpukan
kotoran dan debu
 Menghindarkan cacat kualitas produk
 Mencegah hama masuk ke area pabrik/produksi
Design Layout
Design Principles
Keep in mind:
 Material flow
 People flow
 Process flow

Ensure logical flow

 Bangunan
Example of Materials and People Flow *
Bahan Masuk Staff/tamu masuk Karyawan Masuk Produk Keluar

QC Offices Canteen
Gowning
Incoming Material Flow
goods Shipping
Corridor
Corridor People Flow
Corridor
Zone: Clean
Raw
Materials Zone: Packaging
Finished
Packaging
& Filling Products
Packaging Weighing Processing
Zone: Controlled
Storage
Storage

Washing Machine
Shop

Corridor
Utilities and Services Waste Treatment
Bangunan
Construction
 Suitable materials: bahan yang cocok untuk memastikan
pembersihan yang tepat, tidak retak, dan bahwa bangunan
dapat menahan tekanan, getaran dan efek lainnya.
 Electrical supply: konstan dan mencukupi untuk alat dan
instrumen
 Suitable lighting (especially for visual on-line checks)
 Temperature and relative humidity control
 Appropriate and effective ventilation
These may affect products during manufacture or storage
as well as functioning of equipment
Basic Principles of GMP

 Suhu dan Kelembaban

harus di kontrol,
dimonitor, sesuai dengan
SOP dan hasilnya
tercatat. Batas/spesifikasi
harus sesuai dg
persyaratan proses
produksi dan
penyimpanan
material/produk
 Bangunan
Construction
 Perhatikan Area rawan: Dust generating operations
 e.g. during sampling, weighing, mixing, packing of
powders, etc.)
 Measures should be taken to prevent cross-
contamination  tekanan udara
 Measures to facilitate cleaning  dust collector
Basic Principles of GMP
Design of areas for
weighing of materials
 Proper air supply
 Dust control measures
(including extraction of
dust and air)
 Easily cleanable surfaces
 No areas for dust
accumulation
 Protection of material,
product and operator
 Area Bengkel/Maintenance

 Careful maintenance done

 Repairs and maintenance should not present any
hazard to the quality of the products
 Bengkel utama terpisah dari area produksi
 Tools khusus untuk repair in place  lemari khusus di
area produksi
Basic Principles of GMP
 Storage areas - 1

 Gudang penyimpanan harus mempunyai kapasitas yg

cukup

 Tertib penyimpanan sesuai kategori bahan atau produk

 Area terpisah: starting materials, packaging materials,

intermediates, bulk, finished products, quarantined,
released, rejected, returned and recalled products and
materials
Basic Principles of GMP
Basic Principles of GMP
 Storage areas - 2

 Appropriate temperature and relative humidity

conditions within defined limits
 Provided, controlled, monitored and recorded
 Good storage conditions: clean, dry and appropriate
lights
 Storage areas - 3
 Area Karantina: clearly marked and access restricted
 A separate sampling area is the norm: no risk for
contamination or cross-contamination
 Area berbeda untuk: rejected, recalled and returned
materials and products
 Safe and secure areas for highly active, radioactive
materials, precursor, psitropics, narcotics and other
materials (risk of abuse, fire, explosion) gudang api,
Basic Principles of GMP
 Storage areas – 4

Printed packaging materials

 Critical to ensure compliance with correct labelling of
products
 Special attention to sampling
 Special attention to safe and secure storage
 Ensure compliance with specifications, prevent mix-ups
 SALAH PENANDAAN/LABEL = SALAH INDIKASI = FATAL
 Weighing areas

 Weighing operations – in separated areas

 Appropriate design (Area rawan debu)
 Dust control  dust collector
 Permukaan lantai/tembok: Halus,tidak bersudut, kuat,
mudah dibersihkan
 Cleaning procedures and records
 Documentation, e.g. SOPs, logs and records
Basic Principles of GMP
 Production areas - 1
Minimize risk of cross-contamination:
 Fasilitas khusus dan terpisah for some products such as
highly sensitizing materials (e.g. ranitidin) or biological
preparations (e.g. live microorganisms)
 Separate facilities for other products such as some
antibiotics, hormones, cytotoxic substances
 Non-pharmaceuticals normally not in the same facility,
e.g. pesticides, herbicides
 Production areas -2

 Layout sesuai dengan alur dan kebutuhan produksi

 Kebersihan dapat selalu dijaga
 Aruang kerja dan in-process storage yang cukup
 Penempatan peralatan yang teratur dan logis
 minimizes risk of contamination, mix-ups and
missing production steps
 Layout to avoid mix-ups and cross-contamination
 Production areas - 3

 Area terjadi kontak antara raw material, produk ruahan,

kemas primer dengan udara/lingkungan, harus
diperhatikan:
 Interior surfaces (walls, floors, ceilings) – smooth, free
from cracks dan tidak bersudut
 Tidak ada penumpukan partikel
 Easy and effective cleaning
 Disinfection if needed
 Production areas - 4

 Design : instalasi pipa, fitting lampu, dan titik ventilasi –

harus mudah dibersihkan
 Access for maintenance from outside production areas
 Drains of adequate size, and equipped to prevent back-
flow  tidak menyebabkan banjir
Basic Principles of GMP
 Production areas - 5

 Effective ventilation with air control facilities

 Including filtration of air to a sufficient level to prevent
contamination and cross-contamination – also external
environment filter sesuai kelas kebersihan
 Control of temperature and relative humidity
 Regular monitoring of conditions during production and
non-production periods
 Quality Control areas - 1

 QC laboratories should be separate from production

areas
 Separate areas for biological, microbiological and
radioisotope methods
 Suitable design with sufficient space to avoid mix-ups
and cross-contamination
 Suitable space for storage samples, reference
standards, solvents, reagents and records
Basic Principles of GMP
Premises
Quality Control areas - 2

 Suitable construction materials

 Prevention of fumes  pembakaran reaksi kimia
 Ventilation
 Separate air supply (production and QC)
 Separate rooms for some instruments to protect them
from interference (e.g. electrical, vibration, moisture,
etc.)
Premises
Group Session - Option 1
 Buatlah konsep desain bangunan untuk
sediaan/produk berikut. Jelaskan juga alur gerak
personil dan alur gerak material produksinya. Tentukan
dan sebutkan kelas kebersihan dari area yang ada
dalam bangunan tersebut.
1. Sediaan injeksi steril Non Betalaktam
2. Sediaan Antibiotik penisilin
3. Sediaan Antibiotik sefalosporin
4. Sediaan Hormon kontrasepsi
5. Sediaan sirup non betalaktam