Process Validation & Manufacturing Transfer

PHASE 1

Concept
Generation

PHASE 2

Proof of
Concept

PHASE 3

Product Design &
Process Development

PHASE 4

Design Verification
& Validation

PHASE 5

Process Installation
& Optimization

PHASE 6

Process Validation &
manufactoring transfer

Objectives:

Objectives:

The purpose of Phase 6 – Process Validation & Manufacturing Transfer is to complete the validation of the manufacturing process through completion of the Process Qualification (PQ). Upon release of the product for commercialization, and a demonstrated ability to consistently meet quality and cost standards in manufacturing, the process is fully transferred into an ongoing manufacturing environment.
Activities:

  • Prepare Process Qualification (PQ) protocol
  • Train production personnel
  • Execute PQ
  • Initial product launch
  • Transfer product to manufacturing system

Deliverables:

  • PQ protocol and test report
  • Training records
  • Product release
  • Manufacturing systems
 

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