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Introduction To QBD Fix
Introduction To QBD Fix
Introduction To QBD Fix
03 Agustus 2019
Taufik Akbar
E: taufikakbar.90oz@gmail.com
Yogyakarta
Troubleshooting
02 Improvement produk ek-
sisting
Why industries?
Farmasi UAD
Singkatan
API : Active Pharmaceutical Ingredient
DMF : Drug Master File
SPC : Summary Product Characteristic
BE : Bioequivalence
USP : United States Pharmacopeia
NF : National Formulary
Ph. Eur/EP : European Pharmacopeia
BP : British Pharmacopeia
JP : Japanese Pharmacopeia
FI : Farmakope Indonesia
FDA : Food and Drug Association
BCS : Biopharmaceutical Class System
RLD : Reference Listed Drug
PENGEMBANGAN PRODUK
ICH Q8 (Pharmaceutical Development)
ICH Q9 (Risk Management)
ICH Q10 (Pharmaceutical Quality System)
Pengembangan produk
Tujuan:
Untuk merancang kualitas produk dan
proses produksinya agar secara konsisten
menghasilkan performance yang diinginkan
ICH Q8
Informasi dan pengetahuan yang
diperoleh memberikan pemahaman
Parameter kritis umumnya diiden-
ilmiah untuk mendukung pemben-
tifikasi melalui risk assessment
tukan design space, spesifikasi dan
kontrol proses
Trial and error
ICH Q8
Target pengembangan
Quality after
testing
Pemahaman produk dan proses
Quality by De-
sign (QbD)
Control strategies
Is a control plan of a product obtained from comprehensive understanding regarding formula
and process
QTPP
Dosage Form
Route of
administration
Strength CQA
Weight
Assay (efficacy)
Pharmacokinetics
Impurities (safety)
Appearance
Identity C.U. (efficacy)
Assay
Dissolution
Impurities (efficacy)
Content uniformity
Friability
Dissolution
Residual solvents
Case study
Dosage design Immediate release tablet with film coating and without Immediate release design needed to meet
Score label claims
Route of Oral Same as RLD
Administration
Dosage strength Each film coated tablet contains 500 mcg PDE-4 Pharmaceutical equivalence requirements:
same strength
Pharmacokinetics The absolute bioavailability of PDE-4 following a 500 Bioequivalent requirement compared to RLD
mcg oral dose is approximately 80%.
Tmax PDE-4: approximately 1 hour (0.5 – 2 hours) in
the fasted state
2 Strategi Bioequivalen
3 Patent
4 Discussions