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Flow Chart Process Validation

This document outlines the process validation flow for a new product, including notifying departments, initiating validation protocols, manufacturing batches, conducting quality control analyses at various stages, and preparing and approving process validation reports. The process involves the supply chain notifying departments of the new product, R&D initiating validation protocols within 5 days, production manufacturing batches through various stages like blending and coating with quality checks at each stage, and R&D preparing and submitting process validation reports to quality for approval and distribution.

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masthan6y
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Download as DOCX, PDF, TXT or read online on Scribd
3K views

Flow Chart Process Validation

This document outlines the process validation flow for a new product, including notifying departments, initiating validation protocols, manufacturing batches, conducting quality control analyses at various stages, and preparing and approving process validation reports. The process involves the supply chain notifying departments of the new product, R&D initiating validation protocols within 5 days, production manufacturing batches through various stages like blending and coating with quality checks at each stage, and R&D preparing and submitting process validation reports to quality for approval and distribution.

Uploaded by

masthan6y
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Yes

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Supply Chain
To include the new product in mfg plan
And notify all concerned department within 5 days
Existing Product
New Product
PV for 1
st
three batches
R & D
To initiate PV Protocol within 5 days
Production
To Manufacture the Batches
Stage 1
Blending
Stage 2
Compression/Core

Stage 3
Coating

QC Analysis 3 days
QC Analysis 3 days
QC Analysis 3 days
Stage 4
Packaging
QC Analysis 5 days
Stage 5 (5 days)
QC Release & Reports to R&D
R & D
To prepared & submit the PVR to
QU (5 days)
Quality Unit
to approve and distribute PVR to
all Concerned by R&D (1 day)
Process Validation Flow
Requesting Department to
check the mfg plan with SC
Requesting
department to
bear the cost of
PV under their
budget.

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