Change Request Form






Company Name
Quality Assurance Department

Subject:-    Change Request Form


Revision No.:

Issue Date:


Change Entered by


Identification of Change


Product / Item

Initiating Department

Change Application #








Description of Changes:

1.      
Master Formula


7.
Analytical Method

2.      
 Mfg Procedure


8.
Primary Packaging

3.      
Vendor Change 


9.
Secondary Packaging

4.      
Batch Size


10.
Artwork

5.      
Brand name change


11.
Premises of Factory change

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


Regulatory


Engineering


Warehouse


Purchase


Marketing


R & D


Quality Control


Micro. / Validation


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)












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