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QA

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

HUMAN LABELLING &


RESOURCES- PRODUCT
PROFESSIONALS INFROMATION

DRUG
RAW PRODUCT
MATERIALS- QUALITY QC &
ACTIVE & ANALYSIS
INACTIVE

TRANSPORT
MANUFACURING DISTRIBUTION
PROCESSES DISPENSING
STORAGE & USE
& PROCEDURES
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Quality Assurance: Essential At All
Stages
Quality Assurance Cycle

Research
Development
Raw Materials
Facilities
Documentation
Equipment
Personnel

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