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.
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 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:                      ______________________________________________________________________________________________________________________________________________________

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

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

           
Technical Director
Signature
Date

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 Date of CCF
Name of Originator
Originating Department
Title of Change
Approved
or Reject
Effective Date of
Change
Verified
by QA
Sign. /
Date
Remark













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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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