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GMP_Advanced_ChangeControl
MYLEE - Vulcain
Created on February 10, 2025
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Good manufacturing practices (GMP):Change Control
MYlee
DIGITAL LEARNING
Summary
- Introduction
- Change Control Procedure
MYLEE
Introduction
MYlee
DIGITAL LEARNING
Introduction
Introduction
EudraLex - Volume 4 Good Manufacturing Practice (GMP) guidelines
In the pharmaceutical industry all process must be validated, and each equipment and premise must be qualified. When changes must be made to these systems, these changes must first be evaluated along with all required actions before it can be implemented.
Part I - Basic Requirements for Medicinal Products
Chapter 1 - Pharmaceutical Quality System (Into operation since 31 January 2013)
Xii Arrangements are in place for the prospective evaluation of planned changes and their approval prior to implementation taking into account regulatory notification and approval where required;
Xiii After implementation of any change, an evaluation is undertaken to confirm the quality objectives were achieved and that there was no unintended deleterious impact on product quality;
ii Critical steps of manufacturing processes and significant changes to the process are validated;
MYLEE
Change Control procedure
MYlee
DIGITAL LEARNING
* Can include the validation of the modified process accordingly
Change Control procedure
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
Changes can be driven by :
Innovation
Deviations
Continual improvement
Process performance outputs
Quality monitoring
MYLEE
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
Should include both the current and desired state and the reason why the change is requested Also assign a responsible person overseeing the change and put forward a deadline
MYLEE
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
Determine which areas will be impacted by your change Determine the possible risks associated with these changes
MYLEE
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
Based on the impact assessments, determine the different tasks and assign a responsible person and a due date
MYLEE
10
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
The change and the different actions need to be pre-approved at least by a QA responsible before the change can be implemented!
MYLEE
11
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
After all the actions have been implemented, properly documented, validated, the effectiveness of change should be evaluated
MYLEE
12
Change Control
Change control procedure
Close change request
Open new change request
Impact assessments
Approval of change request
Evaluate results
Determine scope of change
Determine action plan
Implement action plan*
Approval of actions and results
Only after approval of all the finished tasks and the final results by all different parties can the change request be closed
MYLEE
13
Change Control management
MYlee
DIGITAL LEARNING
Change control management
Change Control management
All changes and their status should be tracked through a common database (closed changes included) The content of each change should be accessible to every authorized people within the company. It is good practice to consult the database for similar changes in the past when opening a new change request. Large plants / firms use to put in place a “Change Control Committee” where representants from all potentially impacted functions give their input The responsible person should set a realistic due date and make sure this deadline is respected!
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References
References
- Eudralex Volume 4: Part 1, chapter 1 – Pharmaceutical Quality System - ICH Q10: Pharmaceutical Quality System (04/06/20228)
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Contact us: mylee@vulcain-eng.com
www.vulcain-eng.com
by Vulcain engineering
DIGITAL LEARNING
17
MYlee
Purpose of Change Control:
Required for all changes to the following subjects:
Clear documentation of the change and decision-making process
Product
Validated process
Starting material, product component, range, batch size, ...
Product method, analytical testing, ...
System with direct impact on quality / reproductibility
Evaluation of its impact on quality (may include Risk Assesment)
Quality management system
Equipment, permises, design space
Implementation and follow-up of clearly defined action steps
Exceptions: Lay-out changes, correction of typo’s, adding clarifications, ‘like-for-like’ replacements with equivalent pieces of equipment