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Change Control Form: Page 1 of 5 F1/Qa-Xxx/Nn

This 5-page document is a change control form used by a pharmaceutical company to document and approve proposed changes. It includes sections to describe the proposed change, reason, implementation details, impact assessments by relevant departments, and approvals. If approved, it is used to track the change and conduct post-implementation review.

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Latesh Hole
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© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
409 views

Change Control Form: Page 1 of 5 F1/Qa-Xxx/Nn

This 5-page document is a change control form used by a pharmaceutical company to document and approve proposed changes. It includes sections to describe the proposed change, reason, implementation details, impact assessments by relevant departments, and approvals. If approved, it is used to track the change and conduct post-implementation review.

Uploaded by

Latesh Hole
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 5

Reference SOP NO.

: QA-XXX/NN
Company Name Company Logo
Change Control Form

1) Do not retain this form and forward to the next after completion of review.
2) Put N/A where not applicable.
3) Attach an additional sheet if required as annexure.
4) Please specify the details in case of “others”.
Name of Initiating Department :
Put a √ on area affected and X mark if not.
Change requested for: Temporary change: Permanent change:
Manufacturing Process Specification
Equipment Analytical Instrument
Instrument Analytical Method
Facility (Building / Layout) Service pipelines
Utilities SOP / Formats
Raw Material/Packing Material Any other
Document No. :
Existing System :

Proposed Changes :

Reason / Justification for Change :

Reference / Supporting Data (If Applicable) :

Change Implementation Details:


Tentative Implementation Date: From Batch No. :

Prepared By Checked By Approved By


Name
Designation
Signature
Date

Issued by : Copy No. :


(Sign/date )

Page 1 of 5 F1/QA-XXX/NN
Reference SOP NO. : QA-XXX/NN
Company Name Company Logo
Change Control Form

Initiator Name : Designation : Sign/ Date :


Concurrence From Department Head :

Name : Designation : Sign/ Date :


Initial Assessment By Quality Assurance Department :
Change Control No. : CC-XXX-NNN/YY * Assigned By (Sign/ Date):
Proposed Document No.: Revision No.:
(Put √ mark in the block provided with department Name if assessment required and if not then put X
mark in a box provided.
Name : Designation : Sign/ Date :
Impact Assessment By Quality Control :

Name : Designation : Sign/ Date :


Impact Assessment By Regulatory Affairs :

Name : Designation : Sign/ Date :


Impact Assessment By Engineering & Utility :

Name : Designation : Sign/ Date :

Prepared By Checked By Approved By


Name
Designation
Signature
Date

Issued by : Copy No. :


(Sign/date )

Page 2 of 5 F1/QA-XXX/NN
Reference SOP NO. : QA-XXX/NN
Company Name Company Logo
Change Control Form

Impact Assessment By Production :

Name : Designation : Sign/ Date :


Impact Assessment By Stores (RM & FP) :

Name : Designation : Sign/ Date :

Impact Assessment By Personnel & Administration :

Name : Designation : Sign/ Date :


Impact Assessment By Environment Health & Safety :

Name : Designation : Sign/ Date :


Impact Assessment By Others :

Name : Designation : Sign/ Date :


Impact Assessment By Quality Assurance: Are the changes likely to affect the following? (Put √
mark if yes and X mark if not)

Prepared By Checked By Approved By


Name
Designation
Signature
Date

Issued by : Copy No. :


(Sign/date )

Page 3 of 5 F1/QA-XXX/NN
Reference SOP NO. : QA-XXX/NN
Company Name Company Logo
Change Control Form

Training status GMP / regulatory requirements


Validation Status Changes are to be inform to drug authorities/ Regulatory
authorities
Qualification Status Changes are to be informed Customer
Stability of product Others
Category of Change : Major Minor
Comment from Quality Assurance :

Action to be Taken :

Name : Designation : Sign/ Date :


Approval By Head Quality Operations :
Comment:

Changes are Approved /Not Approved.


Name : Sign/ Date :
POST IMPLEMENTATION REVIEW
Comment from head initiating department:

Name : Sign/ Date :

Prepared By Checked By Approved By


Name
Designation
Signature
Date

Issued by : Copy No. :


(Sign/date )

Page 4 of 5 F1/QA-XXX/NN
Reference SOP NO. : QA-XXX/NN
Company Name Company Logo
Change Control Form

Review of compliance to planned actions by Quality Assurance :


Comment:

Change is approved as temporary change / permanent change.


Change need to make permanent. / not needed to make permanent.
Name : Designation : Sign/ Date :
CLOSURE OF CHANGE CONTROL
Changes Effective Date : Batch No.:
Revised Document Name : Revised Document No.:
Comment:

Name : Designation : Sign/ Date :


Regulatory submission / Notification detail:

Name : Designation : Sign/ Date :

* Where CCT stands for Temporary Change Control & CCP stands for Permanent CC,

XXX stands for Dept. Code, for ex. QA, QC, PRD, ADM, WH etc.

NNN stands for sequential no. of change control

YY stands for last two digits for the current year, for ex. 19 for 2019

Prepared By Checked By Approved By


Name
Designation
Signature
Date

Issued by : Copy No. :


(Sign/date )

Page 5 of 5 F1/QA-XXX/NN

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