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)