SOP For Procedure For change control system

SOP For Procedure For change control system

  • OBJECTIVE 
  •     To lay down the Procedure for change control System.
  • SCOPE
    • The purpose of this SOP is to describe in details the change control process. This procedure starts from initiation to the implementation of the change at Pharmaceutical Company.
  • RESPONSIBILITY
    • Originating/ initiating Department:
    •     To initiate the proposed change and to validate the proposed changes are justified.
    •     To implement the change after approval.
  • QA department:
    • To handle, assess & monitor the change.
    • To close the change control procedure after implementation.
  • ACCOUNTABILITY
    • Manager-Quality Assurance.
    •      To approve / reject the proposed change control.
    • After closing review the change control procedure.
  • PROCEDURE
    • Definition: Change Control Procedure is a documented procedure which explains any permanent / Temporary change in the existing system/facility/process/document etc.
    • Initiation of Change Control Procedure:
      • Any staff from the initiating department can initiate a change control.
      • Firstly the initiating department shall give requisition to Q.A. for a Change Control Form. (Refer the Format No. SOP/QAD-003/FT01-00)
      • The Q.A. personnel shall issue the change control procedure form to the concerned department.
      • In the Change Control form the initiating department shall mention the details of existing system, proposed change & justification for the change.
      • The QA personnel shall check the above details & mention the level of change as well as scope of change in the column of change control form.
  • Level of Changes:

Level I: Changes that do not have any detectable impact on the quality attributes.

Level II: Changes that are likely or may have minor impact on the quality attributes.

Level III: Changes that are having significant major impact on the quality attributes.

  • Mention the scope of change in the format. (According to the Appendix)
  • After this, submit the Change control form to Manager-QA.
  • Change Control Procedure Approval/ rejection:
    • After reviewing the Change Control Procedure Form, Manager-QA shall approve / reject the change purpose.
    • If the Change proposed is approved, then Manager-QA shall mention the changes required column in the Change Control Procedure form.
    • After approval / rejection the Change Control Form shall given in Q.A Department.
  • Assessment of the Change Control Procedure / Change Implementation / Action Plan by QA:
    • After acceptance of the Change purpose, the responsible QA personnel shall review it.
    • A. shall assign a number for the Change Control Procedure according to its numbering system. The numbering pattern for Change Control procedure consists of 14 characteristics.

Such as; PC/CCP-YY-XXX

Where, PC stands for Pharmaceutical Company.

‘CCP’ stands for Change Control Procedure,

‘-’ stands as separation,

YY stands for the last two digits of running calendar year i.e. 19 for 2019,

‘-’ stands as separation,

‘XXX’ stands for the last three digit of the serial no. of change control.

  • After assigning the change control numbering, the Q.A. personnel shall do entry in the Change Control Procedure log. (Refer the format no. PC/CCP-YY-XXX)
  • A. shall review the impact of change on the related documents & arrange to do changes in those documents.
  • A. shall be responsible for the monitoring as well as execution of the proposed change according to its tentative date of completion.
  • It is the responsibility of Q.A. to verify that whether the change is implemented as per the proposal or not.
  • Closing of Change Control Procedure:
    • After the implementation of the change, the Q.A. shall collect the related documents & attach the previous as well as implemented documents with the change control procedure form. Change control procedure should be closed with in 30 days after the issuance of change control form.
    • The implementation of the change will be reviewed.
    • Then Q.A. personnel shall complete the Change Control Procedure log.
    • VP – Plant & Operations shall approve the closing of Change Control Procedure after ensuring the completion of Change along with the other related requirements.
  • ABBREVIATIONS
  • CCP –  Change Control Procedure
  • QA –  Quality Assurance
  • Attachments:
Sr. No. Title  Format No.
7.1 Change Control Form. SOP/QAD-003/FT01-00
7.2 Change Control Log. SOP/QAD-003/FT02-00
7.3 Flow chart for Change Control Procedure SOP/QAD-003/FT03-00

 DISTRIBUTION LIST

Sr. No. Copy No. Department
8.1 1 Quality Assurance
8.2 2 Quality Control
8.3 3 Quality Control – Microbiology
8.4 4 Production – Tablet Section (General)
8.5 5 Production – Liquid Section (General)
8.6 6 Production – Capsule Section (General)
8.7 7 Production – Powder Section (General)
8.8 8 Production – Tablet Section (Beta-Lactum)
8.9 9 Production – Powder Section (Beta-Lactum)
  8.10 10 Production – Capsule Section (Beta-Lactum)
 8.11 11 Engineering & Utility
 8.12 12 Personnel & Administration
8.13 13 Warehouse
  • Revision History:
Sr. No. Revision Number Reason of Revision
1 00 New Sop

 

                                           Attachment – I

                     CHANGE CONTROL PROCEDURE FORMAT

CCP. No.

(To be filled by Q.A.)

Tentative date of implementation
Originating Department Name of Originator

 

EXISTING SYSTEM
 

 

 

 

Originating Dept.

(Sign/Date)

PROPOSED SYSTEM
 

 

 

 

Originating Dept.                                                                                       Manager of Originating Dept.

(Sign/Date)                                                                                                (Sign/Date)

 

JUSTIFICATION FOR THE CHANGE PROPOSED

 

 

 

 

 

 

 

HOD of Originating Dept.                                                                              Reviewed By QA

(Sign/Date)                                                                                                      (Sign/Date)

LEVEL OF CHANGE

Level-I □                            Level-II □                             Level-III □

 

 

Quality Assurance

(Sign/Date)

SCOPE OF CHANGE
 

•    C01                 •     C02                   •     C03                   •     C04                  •     C05

 

(Tick whichever is applicable)

Quality Assurance

(Sign/Date)

 

TO BE FILLED BY Manager-QA

RELATED DOCUMENTS TO BE CHANGED
Standard Operating Procedure (SOP) Validation ( Process/Cleaning/Others) specify
Batch Manufacturing record Stability Protocol
Batch Packaging record General Test Procedure
Master Formula Record Method of Analysis
Specification Site Master File
Formats (Specify) Qualification (DQ /IQ/OQ/PQ)
Put tick mark whether applicable (√).
Others (If Applicable):

 

 

 

Manager-QA

(Sign/Date)

FINAL APPROVAL OF  CHANGE CONTROL BY (VP-Plant & Operations)
Change Approved Change Rejected
Put tick mark whether applicable (√).
 

 

VP-Plant & Operations

(Sign / Date)

 TO BE FILLED BY Q.A.
Tentative Date of Change Implementation
Effective Batch No.

(If Applicable)

Documents to be change (Document No.)
Date of Closing

 

 

Q.A. (Sign/Date)

 

MONITORING & CLOSING OF CHANGE CONTROL
Sr. No. Action Check Points
01 Whether all applicable documents are revised, distributed  and implemented (Ok / Not Ok)
02 All the superseded documents are retrieved, made obsolete and destroyed. (Ok / Not Ok)
03 The change is implemented as proposed. (Ok / Not Ok)
04 Training is completed and evaluated to all concerned (Ok / Not Ok)
 

05

 

Others, Specify ______________________

(Ok / Not Ok)
Put tick mark whether applicable (√).
Reviewed By Manager-QA

(Sign / Date)

 

 

AFTER IMPLEMENTATION CHANGE CONTROL PROCEDURE REVIEWED (BY VP-Plant & Operations)
REMARKS:

 

 

VP-Plant & Operations

(Sign. / Date)

Format No.: SOP/QAD-003/FT01-00

 

                                                 Attachment – II

                   CHANGE CONTROL LOG

SR.

No.

CCP. No. Originating Dept. Brief description

Of Change Control

Approved/

Rejected

Log in by QA (Sign/Date) Date of Initiation Date of Closing

With QA (Sign/Date)

Remarks

Procedure for review, audit and storage of batch records and testing records

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