Change control within a QMS is a formal process used to ensure that a change to a system is introduced in a controlled and coordinated manner.

1. Change Controls in
Pharmaceutical Manufacturing
By: Kester Anyadiegwu
Sr. QA Specialist

2. Discussion
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What is Change
Control?
Principle of
Change Control
Documentation
Process of
Change Control
Quality Risk
Management
Case Study

3. What is Change Control?
Change control within a QMS is a formal process used to ensure that a change to a
system is introduced in a controlled and coordinated manner.
A change control is not department-specific, rather it is the task of the whole
company.
As the change control is considered an essential element of the pharmaceutical
quality assurance system, it is logical the person responsible is a QA representative.
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4. A change control shouldn’t be verbally discussed in group chat or in during lunch breaks.
It should be documented, approved, and applied within the pharmaceutical quality system.
Documentation should include:
• Request for change
• The reason for change
• The impact of the change
Principle of Change Control
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5. Written Procedure
A written procedure is used to describe the
actions taken if a planned change is proposed.
It consists of the starting material, product
component, process, equipment, premises,
product range, method of production, method of
testing, batch size, design space and any change
during lifecycle that may affect product quality.
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6. Documentation
◦ All change control should be documented
◦ Documentation is the key to GMP compliance
and ensures traceability
◦ Documentation provides the route for auditors to
assess the overall quality of operation within the
company and final product
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7. Knowledge Management
Whenever there is a change, you need
relevant people who can assess the change
People who are knowledgeable in said
change control
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8. Quality Risk
Management
QRM is used to evaluate planned changes
QRM determines potential impact on product
quality, pharmaceutical quality systems,
documentation, validation, regulatory status,
calibration, maintenance, and any other system to
avoid unintended consequences
QRM plans for any necessary process validation,
verification, or requalification efforts
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9. Process of Change Control
Change Initiation
Change Request
Approve
Proposed Change
Request
Evaluation by
other departments
Change
Implementation
Schedule of
Events and
timeline agreed
Change review
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10. A change control can be summarized in the following steps:
Identification: explains the need for a change
Justification: the change is justified by proper
reasoning
Example: what causes the initiator to initiate
initiator to initiate the change?
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11. Review: After initiating and justifying the change, the department head will review the change request form
The head will ensure that the change is justified correctly and will not decline quality, product, or process performance. The head will
also check to see whether the required documentation is appropriately completed or not.
If the head does not approve the change, the process will stop.
If approved, the head will forward it to the Quality Department for further action.
Additionally, the QA department will categorize the change according to its category – minor, major or critical.
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12. Review and Approval
Review and approval: The
Quality Department personnel
will review the change request
form and attached documents.
Kickbacks: If there are any
shortcomings, they will be sent
back for correction.
Qualification: When the
Quality head is satisfied with
all requirements, the final
approval will be given.
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13. Communication: QA Department will
communicate the status of the change control
initiating department.
Training: Before the initiator department starts
implementing the change, the Quality
department to implement the change smoothly.
The Quality Department will highlight the
deadlines for effective implementation.
eQMS software:
◦ Documents employee training
◦ Proven method for showcasing training
change. (Ex. ISO, VEEVA, BLUE MOUNTAIN)
◦ The system allows you to easily present audit-
evidence during regulatory audits
The Roles in Quality
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14. Implementation
Implementation: The department will
implement the change control process per
Quality Department directives.
After the change is implemented, the
department will inform the Quality
Department to review and approve the
implemented change.
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15. Evaluation
Lastly, the initiator department will be
evaluated to track the change control
process’s progress and ensure satisfactory
implementation.
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16. Change Control in Pharma
How Do I Initiate Change Control in the Pharmaceutical
Industry?
Change control in the pharmaceutical industry is
request form. The initiator department’s personnel will
relevant information in their relevant fields such as, the
originating department, existing process, proposed
assessment, and reason of change.
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17. Change Control
vs. Deviation
The main difference between change control and
deviation is that change is an updated stage that
conforms to the regulations and quality principles.
Deviation is also an updated stage that does not
conform to the regulations and quality principles.
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18. CASE
STUDY
A new site went live with the Veeva Vault Edms from a paper document system
that had been in place. The business administration and investigation owner
associate changed the overlay in the production environment to the agreed
standard.
Those representatives misunderstood the requirements and initiated the
change without a change control based on the agreed upon standard for the
standard for the overlay.
Root cause = OVERSIGHT
◦ Poor communication
◦ Poor turn road
◦ Ineffective documentation
◦ Training not integrated with change (adequate training of personnel is a
personnel is a prerequisite in both FDA and ISO environment)
environment)
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19. Case Study: Implementation and Evaluation
The admin conducted the investigation contained in this event, and sufficient awareness was
considered established. With the manual process in place, the audit trail provided by Veeva, and
the heightened awareness brought to the representatives about this investigation, no further
actions were required.
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20. Thank You
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21. Change Controls in
Pharmaceutical Manufacturing
By: Kester Anyadiegwu
Sr. QA Specialist