CHANGE

CONTROL
PROCEDURE
Yogendra Ghanwatkar
 ORIGIN OF
CHANGE CONTROL

The term Change Control is

given by NASA
Definition of Change Control
 A written procedure to initiate, evaluate,
approve, implement and close the changes
with documentation in
 Facility
 Process
 Specification
 Documentation
 Test Procedure
 Equipments
 Instruments
 Systems
that may affect the Quality of Product.
 Stages of
Change Control Procedure
 Change Initiation
 Pre Review and Evaluation of Change
 Approval of Change
 Implementation of Change
 Evaluation of Change after Implementation
 Closure of Change

 SOP No. for “Change Control Procedure” is

“------.
 Change Initiation
A request for Change Control Form
raised from Concerned Department
to QA Department.
 Issuance of CCF
 Completion of CCF by Concerned
Department duly signed by HOD-
conc.Dept. and Plant Head.
 Submission of CCF to QA Department
Cont.
 Allocating a Change Control Number by QA
Dept. to filled CCF as: CC/YY/NNN.
Where,
CC:- Change Control
YY:- Last two digit of calender Year
NNN:- Serial Number of Change

For Example:CC/18/001- First Change

Control Raised in Year 2018
 Pre Review & Evaluation
Pre-evaluation by QA ( List of
Activities to be performed)
Change Control Committee
Remarks of Head-QA and other
Departments.
 Approval of Change
Summarization of Comments of CCC
Final assessment & Approval by Head-
QA ( If require forwarded to CQA)
Intimation of decision to concerned
department by QA.
 Implementation
InitiatorDepartment shall
Implement the Change (s), as
suggested by Head-QA.
 Evaluation of Change after
Implementation
Post Implementation results evaluated by
CCC for its effectiveness for:
 Training
 Results of Validation Study
 Analytical Results
 Stability Data
Changes made Permanent
Review of Documents affected by change
 Closure of Change
Approvalfrom Plant Head & Head-QA
CCF Submitted to Documentation
Cell.
 Flow Chart for CCP
Initiation of Change
Control by initiator Filled Change Control Assigning the Change
Department form duly Form from Initiating Control number &
authorized by Department to QA recording in log book
Departmental HOD and
Plant Head
Review CC Form by Head-QA
for Approval / Rejection
QA head rejects change Review and Evaluation
control if found against of Change by Change
policy or cGMP or cGLP Control Committee
Approved

Implementation of Change(s)

Intimation to Initiating
Department for rejection
Post Implementation of proposed change
Review & Evaluation of
Change(s) Made

Submission to
Final review Head-QA & Documentation
Plant Head & change Cell
control closure
Description of Annexure-I of SOP
No.BQA-011
Description of Annexure-II of SOP
No.BQA-011
Questions ?