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Change Control Form

The Change Control Form outlines a structured process for initiating, evaluating, and approving changes within an organization. It includes multiple phases such as initiation, evaluation, departmental feedback, and final approval, with specific assessments on the impact of changes on various aspects of operations. The form is designed to ensure thorough documentation and communication across relevant departments before implementing any changes.

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287 views2 pages

Change Control Form

The Change Control Form outlines a structured process for initiating, evaluating, and approving changes within an organization. It includes multiple phases such as initiation, evaluation, departmental feedback, and final approval, with specific assessments on the impact of changes on various aspects of operations. The form is designed to ensure thorough documentation and communication across relevant departments before implementing any changes.

Uploaded by

qa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

CHANGE CONTROL FORM

A. PHASE-I: Initiation of Change Control


Change Control Form
No. CC/………. /………. /…………
(To be assigned by QA)
Date
Change Control Initiated
Proposed Change Control Section/Stage/Others
by

Sign/Date

Change In  Procedure  Specifications / Analytical Procedure  Facility


 Raw / Packing Materials  Equipment  Documents  Utilities
 Manufacturing Process  Other _________________________

B. PHASE-II: Change Evaluation (Assessment)


Types of Change Control Permanent/Temporary
Category Critical / Major / Minor
Note: Phase-II should be performed by the user department and Quality Assurance (Filled by Asst.
Manager / designee)
a. Impact of Change on product Name/Code/Manufacturing area Code: {Yes / No}
b. Impact of Change on Process Validation: {Yes / No}
c. Impact of Change on Method Validation/Cleaning Validation/Stability: {Yes / No}
d. Impact of Change on Qualification (Equipment/Instrument/Area/and System): {Yes / No}
e. Impact of Change on Hold time the study: {Yes / No}
f. Impact of Change on Specification i.e. (RM/PM/FP/STP/Stability): {Yes / No}
g. Impact of Change on SOP/Layout/SMF/MFR/MPR/VMP/Quality Manual/Quality Policy:
{Yes / No}
h. Impact of Change on Preventive Maintenance/Calibration schedule: {Yes / No}

B. PHASE-II: Change Evaluation (Assessment) Continue…….


i. Impact of Change on BMR/BPR/Process Flow Sheet: {Yes / No}
j. Impact of Change on list of equipment/instruments: {Yes / No}
Comment of User Department Comment of Quality Assurance Department

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CHANGE CONTROL FORM

Sign/Date Sign/Date
C. Phase-III Comment of Relevant Department / s Feedback (if necessary):

(Sign/Date)
D. Phase-IV Comment of User Department Head (Preventive and Reoccurrence):

(Sign/Date)
E. Phase-V Approval of Change Control:

Approved / Not Approved (Sign/Date)


F. Phase-VI: Implementation of Change: Yes/No; Document/Other Details:

G. Phase-VII: Change Control Form Closure (Date):

To be circulated to the following departments (Xerox copy):


 QC  PD  ST  EM  HR  FD
 Any other department, Specify _________________________________
Note: Attach separate sheet if required…….

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