Company Name
|
Quality Assurance
Department
|
Subject:- Change Request Form
|
|
Revision No.: |
|
Issue Date:
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Change
Entered by
|
Identification
of Change
Product / Item
|
Initiating Department
|
Change Application #
|
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Description
of Changes:
1.
|
Master Formula
|
7.
|
Analytical Method
|
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2.
|
Mfg Procedure
|
8.
|
Primary Packaging
|
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3.
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Vendor Change
|
9.
|
Secondary Packaging
|
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4.
|
Batch Size
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10.
|
Artwork
|
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5.
|
Brand name change
|
11.
|
Premises of Factory
change
|
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6.
6
|
Layout / Drawing
|
12.
|
Testing Method
|
Description:
(Use
separate sheets if required)
Existing
|
Proposed
|
Reason for Change:
|
Tentative date of implementation
|
Types of Change:
|
Temporary
|
Permanent
|
Emergency
|
Category of Change:
|
Critical
|
Major
|
Minor
|
Initiated by
|
Date
|
Review
& Approvals of concern departments:
Department / Section
|
Comments & Suggestions (if any)
|
Signature / Date
|
Production
|
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Regulatory
|
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Engineering
|
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Warehouse
|
||
Purchase
|
||
Marketing
|
||
R & D
|
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Quality Control
|
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Micro. / Validation
|
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Quality Assurance
|
Change implementation
plan: (If require, use
Cutoff Date Action Plan / use additional sheet)
Action Required
|
Responsibility
|
Timeline
|
Change
approval:
Department
|
Remarks
|
Signature / Date
|
QA Manager
|
¨ Change recommended.
¨ Change not
recommended.
|
|
Director
|
Change
¨ Approved.
¨
Not
approved.
|
Change
completion / closeout.
Comments / Remarks
|
Verified by:
|
|
QA Manager
(signature / date)
|