Pharmaceutical Industry

Learning outcome
01 Pharmacy Industry in Indonesia
02 Registration
03 Building and facility, water treatment
and waste
04 Raw material, packaging material
and finished product
05 Manufacturing process
06 RnD
07 Quality Assurance and Quality
Control
Armstrong, N.A., and James, K.C., 1996, Pharmaceutical Experimental Design and Interpretation. Taylor and
Francis, Bristol.

Aulton,M.E., 1988, The Science of Dosageform Design, Churchil Livingstone, Edinburgh.

Avis, K.E., Lachman, L, and Lieberbamn, H.A., 2000, Pharmaceutical Dosageform : Parenteral, Tablet,
Disperse System, vol I, II, III, Marcel dekker Inc., New York.

Banker, G.S. and Rhodes, C.T. 2002, Modern Pharmaceutics, 3rd. Ed., MNarcel-Dekker Inc., New York.

Gennaro A.R, 2013, Remington : :The Sience and Practice of Pharmacy,

22nd Ed., Mack Publ. Co., Pensylvania.

Lachman, 1986, The Theory and Practice of Industrial Pharmacy, 2nd, Ed.,
Lea & Febiger, Philadelphia.
 Class Rules
Time Evaluation
1 SKS Theory : 50/45 minutes Mid exam : 35%
2 SKS Practice : 2 x 160/145 minutes Final exam : 35%
200 minutes practice lab Task + soft skill (include quiz) : 30%
120/90 minutes yaitu pre dan post practice
UP I : 30%
Late maximum : 10 minutes? UP II : 35%
Presence >80% UP III : 35%

No eat and snacking, No SLEEP! Final score : ((NT X SKS) + (NP X SKS))/Total SKS
Keep the camera ON during class
Drink is allowed
Keep the class comfortable for everyone
Pro active!!
Pharmaceutical Industry History
18th century 19th century 19th century 19th century

PABA Apothecaries Antimicrobial Vaccine

Chemical companies Plant-based extracts

Next 2010 20th century

Personalized NDDS Patent drug

Biotechnology Copy drug

 New disease
Why there New entity with better performances

is always 1.Microbial resistance

2.Broad or specific spectrum
3.Higher potency
something 4.Pharmacokinetics
5.Stability
6.Theurapetic window
new? Availability
 Product development schedule
• Chemical and
pharmacological
Clinical testing IV
studied
• Literature • Development • Test area
• Drug regulation process • Pilot plant • Trade name • Campaign
• Patent manufacturing • Manufacture • Packaging • Advertising
• Sales potential • Apply for patent material needed • Commercial
• Competitor • Review for clinical manufacture
• Availability investigation research • Trade mark
material result • Clinical research registration
• Availability • Re-evaluate
manufacturing current market
process

Selection Screening Business and Development Testing Commercialization

medical
analysis
 Copy product
Pharmaceutical BPOM
Industry in History
1817 NV. Chemicalien
Indonesia 1896 Pabrik Kina at Bandung
Penjajahan Pendidikan asisten apoteker
1958 Tenaga apoteker berkembang pesat
1958-1967 Undang- undang penanaman modal asing
PMA dan PMDN
1980 Terpuruk  tata cara pemberian izin apotek
2014 JKN

Biotechnology
Chemical
Obat tradisional
Cosmetics
Medical devices
 Registration
PerKaBPOM RI No 24 th 2017
Registration? Who?

Drugs?
Registrasi baru?
Obat baru?
Registrasi variasi?
OGB?
Registrasi ulang?
Obat generik?
Obat dalam
negeri vs impor?
Obat kontrak?
Obat lisensi?
Izin edar? Orphan Drug?

Requirement and CPOB?

criteria?
Requirement and Criteria
 Registration Classification
Obat baru dan produk biologi

Baru Generic dan OGB

Registrasi sediaan lain

Major
Registrasi
Variasi Minor

Notifikasi

Ulang
 Registration process

Pendaftar
Dokumen Registrasi

Kepala Badan
• Evaluasi
• Pemberian keputusan
• Persetujuan/Penolakan/
Peninjauan kembali