1.0
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PURPOSE
To
lay down a procedure for monitoring & control of the initiation, review,
approval & implementation of technical changes in operating procedures,
specifications, manufacturing process, analytical testing methods, equipment,
and utilities and operating environment.
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2.0
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SCOPE
This procedure is applicable to the to all the
changes, which may affect the manufacturing process, formula, facility,
equipment layouts, equipment design / systems & procedures (test
procedures etc.), specifications. These changes may be implemented due to
process, product, customer requirements Or replacement of change parts of an
equipment.
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3.0
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RESPONSIBILITY
Section
In-Charge
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4.0
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ACCOUNTABILITY
Head QA
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5.0
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PROCEDURE
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5.1
5.2
5.3
5.4
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.6
5.6.1
5.6.2
5.6.3
5.6.4
5.7
5.7.1
5.7.2
5.7.3
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.8.5
5.8.6
5.9
5.9.1
5.9.2
5.9.3
5.10
5.10.1
5.10.2
5.10.3
5.10.4
5.11
5.11.1
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For
all the changes, prior approval shall be taken from QA (through the Change
Control Procedure), before implementation.
Typical
changes, which must follow change control procedure, are given below. Any
other changes, which are critical in nature or can have direct impact on the
product quality, shall also follow change control procedure.
Initiator
who has to propose the change shall approach to Head – QA for issuance of
change control form as attached as per Annexure –II.
The
QA officer / executive shall allocate a unique sequential number to each CCF
and maintain a logbook including approved as well as rejected change control
requests as per Attachment-1.
The CCIF number shall consist of 10 alphanumerical
characters e.g. “CC-YYY-MM-001”.
The first two alphabetical characters “CC” shall
indicate “Change control form”.
The Third,fourth, character shall always be
‘Year-‘012 for the year 2012.
The next two numerical characters shall indicate the
month e.g. ’01, 02, 03…..12’ .
The last 3 numerical characters represent the unique
sequential serial number for the form documented, Starting from 001, 002, 003
…… 999. In every month serial number again start from 001.eg. January 01….008,
February 02…..008.
Initiation
of ‘Change Control Initiation Form’:
The concerned departmental officer / executive / Head
shall initiate , by documenting the changes control form in any of the
manufacturing procedures, specifications, manufacturing process / batch
formula, analytical testing methods, equipment, utilities and operating
environment.
The initiator shall record the justification for the
proposed changes. All the relevant data documents, which support the proposed
changes, shall be attached along-with the form.
All the attached data shall be enclosed in the form
of Annexures II.
All the attachments shall be reviewed & checked
by, by the initiating department.
Review of
CCIF:
The CCIF shall be reviewed by department head / Tech.
Director, for necessity / feasibility of the changes proposed, justification
given along with the attachments, and signed off in CCF.
The CCF Shall be reviewed by EHS Deptt for safty concern.
The completed CCF shall be forwarded to the QA
department for approval, prior to the implementation.
Approval of change control initiation form: The Head-QA / Nominee.
The proposed changes shall be classified by Head-QA
/ Nominee, into following three categories, depending upon their impact on
the product quality.
QA shall review the change control with respect to
impact on product quality, necessity/ feasibility of the changes proposed,
rationale / justification of the change &
compliance to cGMP along with the adequacy of the supporting data
attached.
(a) Minor
change - A change that does not have any impact on
the quality of the product and operating
system.
(b)Moderate
change - A change that is likely to have an impact
on the quality of the product, but
does not
make
any significant change in the final quality of the product.
(c) Major change - A change that has a significant impact on quality
and / or safety of the final product.
Head-QA shall evaluate the CCF for the impact on the
quality of the product and shall recommend any additional studies to be
carried out (if required), during implementation of change.
QA may also
recommend additional training, to be given to the personnel involved, in case
of changes in critical procedures.
In case of a change pertaining to the product
manufactured for specific customer on contract basis, prior approval for this change shall
be taken from the customer, by sending
notification of the proposed change (with justification) and the
proposed data shall be generated to support evaluation of the change. Upon
receipt of acceptability from the customer, the change shall be implemented.
Head-QA shall approve the CCF, for implementation,
after satisfying himself that the proposed change shall not have any adverse
impact on the product quality / cGMP compliance / regulatory compliance, and
that all the necessary supporting data, for justification of the changes, has
been attached.
Implementation
of Change:
The changes shall be implemented by initiating
department, after approval of the CCF.
During implementation of the changes, necessary
studies shall be carried out & data shall be collected, as recommended in
the CCF.
The data generated shall be compiled by the
initiating department and forwarded to QA.
Closure of
CCF :
The closure of the change control initiation form
shall be responsibility of the Initiator dept. head & QA head.
QA shall verify whether the recommendations made in
the CCF, have been implemented.
The operating Head / Head QA shall together review
the data generated during the implementation of the change control.
Finally, head-QA shall sign the closure of the CCF.
The closure of the CCF shall also be recorded in the CC logbook.
The documents, which are effected by the
implementation of the change control, shall be reviewed / updated, as per the
requirement.
Archival
of Change control forms:
After approval of a change control proposal, the
Change control form shall be stored / archived in QA department,
systematically.
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6.0
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REFERENCES
SOP guideline by D.H. Shah
cGMP Guideline
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Annexure I
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CHANGE CONTROL LOG BOOK
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QA/019/F01-00
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Annexure II
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CHANGE CONTROL FORM
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QA/019/F02-00
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8.0
|
ABBREVIATIONS
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Abbreviations
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Full Forms
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|||||||||
SOP
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Standard Operating Procedure
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|||||||||
QA
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Quality Assurance
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CCF
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Change control form
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EHS
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Environment Health Safety
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9.0
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DISTRIBUTION
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|||||||||
Master Copy
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Head Quality Assurance
Department
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|||||||||
Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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|||||||||
Controlled office Copy No. 3
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Head Production (Tablet) Deptt.
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|||||||||
Controlled office Copy No. 4
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Head Production (Liquid)
Deptt
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|||||||||
Controlled office Copy No. 5
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Head Production (External)
Deptt
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|||||||||
Controlled office Copy No. 6
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Head Production (Soap)
Deptt
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|||||||||
Controlled office Copy No. 8
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Head Store Dept.(Main Block)
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|||||||||
Controlled office Copy No. 10
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Head Engineering Dept.
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|||||||||
Controlled office Copy No. 11
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Head Store Dept.(External Block)
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|||||||||
Controlled office Copy No. 12
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EHS Head
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|||||||||
10.0
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REVISION
HISTORY
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|||||||||
S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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|||||
1
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Annexure I
CHANGE CONTROL LOG BOOK
Date
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Change
Control No
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Initiated
By& Department
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Details of Change Control
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Approved/
Rejected
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Approved
By/On
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Closeout
of Change Control
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Remark
|
.
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|||||||
Annexure II
CHANGE CONTROL FORM
1.0 Change Initiation
Change Control
Form No. CCIF-___________
Date: ---------------
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|||
1.1
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Sign &Date of
Requestor
(Department)
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||
1.2
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Market
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  Domestic Export |
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If
Export Country / Customer Name:
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|||
1.3
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Change related to:
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  BMR Specifications STP SOP MOA  Equipment Design / Configuration Analytical method  Others (give details) |
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1.4
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Existing Procedure
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||
1.5
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Proposed
Change Details:
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1.6
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Justification /
Rationale for Change:
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1.7
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Enclosure (s)
1.
2.
3.
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||
1.8
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Initiated By/Date
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Checked By/Date
Concern Dept. Head
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1.9
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Attachments /
Supporting Data ( If Applicable)
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||
2.0 Evaluation & Assessment
of Change proposal by QA________________________________
__________________________________________________________________________________________________________________________________________________________________
2.1 Can the Change be made Permanent: Yes No
3.0 Category of Change:
Minor Major Moderate
Permanent Temprovery 
3.2 Any validation / Qualification Documents
Affected : Yes No
Any Process Affected
: Yes No
Any SOP Affected
: Yes No
Any System Affected
: Yes No
Any Equipment Affected : Yes No
Sign
& date:
Head QA
3.3 Training Required:
Yes / No
3.4 Training conducted on:
3.5
Comments from Head of allconcern
departments including EHS Deptt. which are likely be
Affected
by the proposed Change & whether the change is acceptable or not.
Department
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Comments & change
accepted-
Yes/No
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Sign/Date
Designation
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||
Sign/Date
Designation
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·
If change not accepted,
then discuss the reason thereof with concerned department for not agreeing with
the change & inform the requester.
4.0 Implementation of Change:
4.1 Change Control Implemented By:
Implemented By Department
Head
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Name
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Signature
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Date
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4.2 Observations (if any)
4.3 Quality
Profile of batches affected (if applicable):
4.4 Specify if subsequent changes required in
a)
Documentation
b)Training/retraining
c)
Stability testing/Revalidation
4.5 Proposed
Change informed to concern Departments:
Department
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Designation
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Sign/Date
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5.0 QA Review of Implementation & Closure:
____________________________________________________________________________________________________________________________________________________________________
5.1 All
recommendations fulfilled: Yes No
5.2 If No, Justification: _____________________________________________________________________
__________________________________________________________________________________
5.3 If No: Has
the Change been reviewed Yes No
Closure Approved By User Department Head
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Name
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Signature
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Date
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Closure Approved By Head-QA
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