1/20/2020 SOP for Change Control : Pharmaceutical Guidelines

SOP for Change Control

Standard operating procedure for handling the change control in pharmaceutical manufacturing facility.

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 accordingly
3.2 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.

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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).

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1/20/2020 SOP for Change Control : Pharmaceutical Guidelines

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 Procedure
6.2 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:
______________________________________________________________________________________________________________________
________________________________
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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

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9.0 Review of impact of CCF

Comments Reviewed by

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

Signature Date
Technical Director

16.0 Date of implementation of the amend documentation: _________________________

17.0 Amended document distribution on: ______________________________________

ANNEXURE – III
(CHANGE CONTROL LOG BOOK)

S.No. CC No. Issue Name of Originating Title of Approved Effective Verified Remark
Date of Originator Department Change or Reject Date of by QA
CCF Change Sign. /
Date

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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