1.0 OBJECTIVE
To lay down a procedure to define the mechanism for the initiate, review and authorization of changes in all master documents, master system and their control.2.0 SCOPE
This procedure applies to handle the change control at the manufacturing facility.3.0 RESPONSIBILITY
3.1 Executive –Quality assurance - Prepare the SOP and follow-up the SOP accordingly3.2 Asst. manager –Quality assurance & Regulatory affairs -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Technical - Director.5.0 PROCEDURE
5.1 This procedure is applicable to, but is not necessarily limited to all authorized documents/procedure including Validation protocols, Master formula records, Batch manufacturing records, Standard Operating procedure, Finish product specification, Standard testing procedure, Raw material specification, Packaging material specification.5.2 Initial of change (s)
5.2.1 No “authorized” document can be changes without being duly authorized in accordance with this procedure
5.2.2 Each document change request must be initiated by completion of a change control form (CCF) as per Annexure –II.
5.2.3 The Asst. manager of Quality assurance & Regulatory affairs has the responsibility for controlling and tracking the CCF.
5.2.4 The user department shall initiate the changes required by filling and submitted CCF from along with supporting documents to QA department.
5.2.5 Changes to be established must have sound/ scientific justification.
5.2.6 The impact of any proposed change on the quality of the final product must be fully evaluated and documented.
5.2.7 Quality assurance will assign a CCF No. for the documentation.
5.2.8 CCF numbering system: It contains combination of 8 digit and letters.
e.g. XYZ/CC-XXXX
Where XYZ - stands for company initial
CC - Change control
XXXX – 1st X stands for last digit of current year & next 3X’s stands for serial No.
XYZ/CC - 18001 will be CCF No. for 1st change control of the year 2018.
5.3 Management review and approval
5.3.1 Circulate the CCF together with supporting documentation, to the Head – Quality assurance & Regulatory affairs, R&D, Production, Quality control and Warehouse as appropriate for their review and comments. Cost/ Productivity improvements must be fully justified and counter signed by the Plant Head/ Technical Director.
5.4 Review and authorized process
5.4.1 Submit CCF documents to Quality assurance for review and authorization before implementation.
5.4.2 The Head of Quality assurance & Regulatory affairs must assign a category of change to each CCF.
5.4.3 Category ‘A’ - No regulatory impact.
Category ‘B’ - Minor changes (Notification to the Regulatory authorities required)
Category ‘C’ - Major change/s that (Approval from the Regulatory authorities is required before implementation.)
5.4.4 The review and authorised of a change shall include a sign by Head of Quality assurance & Regulatory affairs, Engineering, Quality control, Production, Warehouse and Engineering.
5.4.5 The Head of Quality assurance & Regulatory affairs must ensure that all information (e.g. dates of submission /approval) relating to notification to Regulatory authorities is promptly transmitted to the Departmental heads to authorized the change (if applicable) shall finally authorize all change control (s).
5.4.6 A duly completed change control form as per Annexure- II shall be finally signed by QA dept.
5.4.7 CCF No will have stamping “CONTROLLED COPY” in red colour on right corner on each page of front side.
5.4.8 Schematic diagram of change control as per Annexure-I.
5.4.9 Issuance and controlling record will be maintained in QA department as per Annexure-III.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure6.2 No. - Number
6.3 NA - Not Applicable
6.4 QA - Quality Assurance
6.5 CCF - Change Control Form
6.6 R&D - Research & Development
6.7 RA - Regulatory Affairs
ANNEXURE – I
(SCHEMATIC DIAGRAM OF
CHANGE CONTROL)
ANNEXURE – II
CHANGE CONTROL FORM (CCF)
PART-
A (To be filled by initiating
department) CF No. ____________________
1.0 Change is requested for but not limited to followings:
1.1 Production Department
1.2 Quality control
Department
1.3 Engineering Department
1.4 Warehouse Department
1.5 Human resource
development Department
1.6 QA Department
2.0 Proposed Change: __________________________________________________________________________________________________________________________________________________________________________
3.0 Existing System:
__________________________________________________________________________________________________________________________________________________________________________
4.0 Effective Document(s)
4.1 To be amended:
__________________________________________________________________________________________________________________________________________________________________________
4.2 To be cancelled:
______________________________________________________________________________________________________________________________________________________
5.0 Reason for the
change:
______________________________________________________________________________________________________________________________________________________________________
6.0 Proposed
Name:
Signature:
Date:
7.0 Department Head’s
Name:
Signature:
Date:
PART – B
(TO BE FILLED BY CONCERNED DEPARTMENTS)
MANAGEMENT REVIEW
8.0 Circulated
to
:
Date
_____________________
Production
Warehouse
Quality Control
Engineering
R&D
9.0 Review of impact of CCF
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Comments
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Reviewed
by
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10.0 Cost/Productivity approval (Applicable/ Not
Applicable)
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Head works: ______________ Sign: ________________ Date: _______________
PART - C
(TO BE FILLED BY HEAD –QUALITY ASSURANCE & REGULATORY AFFAIRS)
ASSESSMENT AND AUTHORISATION OF CCF
11.0 Date of
review:
Feasibility
of change: (Yes)
(No)
12.0 Category of change ( refers point
6.4.3)
12.1 Category ‘A’
12.1
Category ‘B’
12.1
Category ‘C’
13.0 Date of regulatory authority
approval (applicable/Not applicable) Date : ________
Signature
of Head - Quality Assurance & Regulatory
Affairs___________________
14.0 QA
Approval:
15.0 Final
approval and authorization
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Technical Director
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Signature
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Date
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16.0 Date of implementation of the amend
documentation: _________________________
17.0 Amended document distribution on: ______________________________________
ANNEXURE – III
(CHANGE CONTROL LOG BOOK)
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S.No.
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CC No.
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Issue Date of CCF
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Name of Originator
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Originating Department
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Title of Change
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Approved
or Reject
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Effective Date of
Change
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Verified
by QA
Sign. /
Date
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Remark
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Sir is it required to initiate change control for the very new SOP.
ReplyDeleteChange control is required for any chance in existing document or system. It is not required for new document.
DeleteBut if we are introducing any new document in the system that may have impact on the existing system then this can be assessed significantly through change control only.
ReplyDelete