Professional Documents
Culture Documents
QUALITY ASSURANCE
Fungsi program Quality
• Quality Assurance
– Meliputi segala hal mulai dari bahan baku dan
verifikasi GMP melalui pelepasan produk jadi
– HACCP adalah bagian dari QA
• Quality Control
– Actual manufacturing process
FACTORS IN DRUG QUALITY ASSURANCE
LEGISLATIVE IMPORT
FRAMEWORK & EXPORT
-REGULATIONS CONTROL PACKAGING
DRUG
RAW PRODUCT
MATERIALS- QUALITY QC &
ACTIVE & ANALYSIS
INACTIVE
TRANSPORT
MANUFACURING DISTRIBUTION
PROCESSES DISPENSING
STORAGE & USE
& PROCEDURES
3
Quality Assurance: Essential At All
Stages
Quality Assurance Cycle
Research
Development
Raw Materials
Facilities
Documentation
Equipment
Personnel