ANNEXURE 1

CHANGE CONTROL RECORD

SECTION A:
Date of
CCR No.
issuance
Area Utility Product System Document T.C.D.
Applicable
to Equipment Material Instrument Other
Ext. I
Title of
Ext. II
Change

Product / Reference
material / Batch No./
Document / AR No. /
Instrument/ Doc. No./
Equipment/ Equipment ID
Area/Utility/ /Instrument
Other ID/Area

Previous change control form No.(if any)

Initiated By
(Name) Logged By
QA (Name)
Department
CHANGE DETAILS
Existing system

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CHANGE CONTROL RECORD
CCR No.:
Proposed change

Justification

Approved by
Initiated by
HOD/Designee
(Sign & Date)
(Sign & Date)

SECTION B:
IMPACT ANALYSIS
Concerned
Impact
Recommendation of Impacted Dept. HOD
Items (Yes/No Action Item No.
HOD/ Designee (Sign &
)
Date)
Process
Quality
Parameter
Calibration
Schedule

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CHANGE CONTROL RECORD

CCR No.:
Concerned
Impact
Recommendation of Impacted Dept. HOD
Items (Yes/No Action Item No.
HOD/ Designee (Sign &
)
Date)
Stability
Process
Validation
Cleaning
Validation
Training
Information
(As per annexure
7)
Hold time
Sampling
Regulatory
Approval
Mfg. product
Lic./COPP
Marketing
Approval
DCGI

Product list
Cleaning/
Passivation/
Sanitation
Preventive
Maintenance
Schedule
Equipment /
Instrument
Master List
Layout/
Drawing/
Diagram
Segregation of
the Area/
Caution Display
Utility Impact

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 ANNEXURE 1
CHANGE CONTROL RECORD
Spec./ATP (RM,
PM,FP,
stability)

CCR No.:
Concerned
Impact
Recommendation of Impacted Dept. HOD
Items (Yes/No Action Item No.
HOD/ Designee (Sign &
)
Date)
MBMR / Mfg.
BOM
MBPR / Pkg.
BOM
SOP / Protocol
LIMS /
METIS/SAP
Qualification
Calibration
Packing
Material/ Pack
style
Change parts /
tooling
Artwork
Rejection /
Destruction
Price, equipment
list
E.H.S.(If yes
annexure)
Risk
Assessment
Cross function
investigation
report
CAPA
MSTG/FDD
Comment
Any Other

Dep. Head
(Sign & Date)

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CHANGE CONTROL RECORD
Impact Analysis Review
by QA Head /Designee
(Sign and Date)

CCR No.:
Notification Comment Sign & Date

Plant Head
SECTION C:
APPROVAL FOR EXECUTION
To be filled by QA Head/Designee
Approved Rejected Change Review Level:  Level I  Level II 
Level III
Approved By Comment Sign & Date
Department Head /
Production Head

Q.A. Head

Site Quality Head

SECTION D:
ACTION ITEM CLOSURE DETAILS
Initiator/ Reference Document Reviewed By
Action Item Action Item
Designee Details QA
Number Completion Date
Sign and Date Sign and Date

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CHANGE CONTROL RECORD

CCR No.:
Action Item Initiator/ Reviewed By
Reference
Action Item Number Completion Designee QA
Document Details
Date Sign and Date Sign and Date

ACTION ITEM CLOSURE EVALUATION

Department Comments Sign & Date
Department
Head

Quality
Assurance

SECTION E:
IMPLEMENTATION AND CHANGE CLOSURE DETAILS
Change implemented Change not implemented
Closure comments:

Yes No
Post changes review requirement (PCRR)
Recommendation for PCRR:

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CHANGE CONTROL RECORD
Checked by QA Head Approved by Site Quality Head
(Sign & Date) (Sign & Date)

CCR No.:
Sign and Date

Change control closer status:  Closed  Not implemented

SECTION F:
POST CHANGES AND EFFECTIVENESS MONITORING DETAILS
Reference Tracking No.:
Mode : APQR / Protocol / Self Inspection /
Target Date
CAPA
Date & Sign
Final
Checked by
Date Observation conclusio Ref. Doc. No.
Sign and Date
n

Documents Attached:
1.

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CHANGE CONTROL RECORD
2.
3.
4.
5.

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