PME- 560A

TERM PAPER

QbD : An essential step for Continuous OSD Manufacturing

ByPrashant Bharadva

Batch vs. Continuous ManufacturingBatch Manufacturing Continuous Manufacturing

Limited production time Production up to 24 hours

Requirement of large floor space Less floor space requirement

Scale-up is tricky Easy to Scale-up

Labor-intensive due to large material handling

Continuous!

Excessive WIP storage No or minimum WIP storage

Large initial capital investment Less initial capital investment

Variation between batches No or minimum variation between two lots

End-point quality check On-line quality control

Implementation of QbD

1. Identify Target Product Profile (TPP)2. Determine Critical Quality Attributes (CQAs)3. Risk Assessment4. Develop Design Space5. Quality Control Strategy6. Continual Improvement of the Product

Traditional vs. QbD System

ConclusionContinuous manufacturing of OSD using QbD;• Reduced labor cost• Less manufacturing space• Energy savings• Reduced time to Market• Real time quality control• Gives improved business opportunity