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GMP Change Control and Deviation Management Audit Checklist

A comprehensive audit checklist for evaluating GMP compliance in pharmaceutical change control and deviation management processes, ensuring systematic control of changes and effective handling of deviations.

GMP Change Control and Deviation Management Audit Checklist
by: audit-now
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About This Checklist

Effective change control and deviation management are critical components of maintaining GMP compliance in the pharmaceutical industry. This GMP Change Control and Deviation Management Audit Checklist is an indispensable tool for evaluating the robustness of processes that manage changes and address deviations in pharmaceutical manufacturing. It focuses on ensuring that all modifications to facilities, equipment, processes, and documentation are properly assessed, approved, and implemented, while also verifying that deviations from standard procedures are adequately investigated and resolved. By systematically reviewing these areas, pharmaceutical companies can maintain product quality, ensure regulatory compliance, and drive continuous improvement in their operations.

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Industry

Pharmaceuticals

Standard

Good Manufacturing Practice (GMP)

Workspaces

Pharmaceutical Manufacturing Facility

Occupations

Quality Assurance Manager
Change Control Coordinator
Regulatory Affairs Specialist
GMP Auditor
Production Manager

Change Control and Deviation Management

(0 / 5)

1
What are the findings from the root cause analysis?

Provide detailed findings from the root cause analysis.

To document the underlying causes of the deviation for future reference.
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2
Is the CAPA implemented for the deviation?

Select the implementation status of CAPA.

To confirm that corrective actions have been taken to address the deviation.
3
What is the risk assessment score for this change?

Provide a score between 1 and 5, where 1 is Very Poor and 5 is Excellent.

To evaluate the potential impact of the change on product quality.
Min: 1
Target: 3
Max: 5
4
What is the description of the deviation?

Provide a detailed description of the deviation.

To understand the nature of the deviation for further analysis.
5
Is the change request approved?

Select the approval status of the change request.

To ensure that all changes are authorized and comply with regulatory standards.
6
What feedback have stakeholders provided regarding the change?

Provide detailed feedback from stakeholders.

To capture insights and concerns from those impacted by the change.
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7
When is the next review date for this change?

Enter the date for the next review.

To schedule follow-up assessments of the change's impact.
8
What are the metrics used to measure improvement after implementation?

Provide the metrics used for measuring improvement.

To evaluate the effectiveness of the change and track improvements.
Min: 0
Target: 0
Max: 100
9
Does the change comply with regulatory requirements?

Select the compliance status of the change.

To ensure that all changes meet the necessary legal and regulatory standards.
10
What is the potential impact of the change on product quality?

Describe the potential impact on product quality.

To assess how the change might affect the quality of the pharmaceutical product.
11
What comments were received regarding the effectiveness of the training?

Provide any comments or feedback on training effectiveness.

To gather feedback on how well the training was received and its effectiveness.
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12
What is the scheduled date for the next documentation review?

Enter the date for the next documentation review.

To ensure that documentation is regularly reviewed for accuracy and relevance.
13
How many staff members have been trained on the change?

Provide the number of staff members trained.

To quantify the reach of the training program concerning the change.
Min: 0
Target: 0
Max: 100
14
Has training been conducted for the staff regarding the change?

Indicate whether training has been conducted.

To confirm that all relevant personnel are trained on the new processes.
15
Is the change documentation complete and accurate?

Select the completeness status of the documentation.

To ensure that all necessary documentation is provided to support the change.
16
What is the action plan following the approval of the change?

Detail the action plan for post-approval activities.

To ensure there is a clear plan for implementing the approved change.
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17
How many reviewers participated in the approval process?

Provide the number of reviewers involved.

To assess the extent of the review and approval engagement.
Min: 1
Target: 0
Max: 10
18
What comments were made during the approval process?

Provide any comments or notes from the approval process.

To document any considerations or remarks made by the approvers.
19
What is the date of approval for the change?

Enter the approval date.

To track when the change was officially approved.
20
Was the initial review of the change completed?

Select the status of the initial review.

To confirm that the change has undergone an initial evaluation before proceeding.
21
Are any additional actions required following this change?

Indicate whether additional actions are needed.

To identify if further steps need to be taken based on the change review.
22
What lessons were learned from the change process?

Detail any lessons learned during the change process.

To capture insights that can inform future changes and improvements.
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23
How many issues were identified post-implementation of the change?

Provide the total number of issues identified.

To track any challenges or issues that arose following the change.
Min: 0
Target: 0
Max: 100
24
Was the change effective in achieving its intended outcomes?

Select the effectiveness status of the change.

To evaluate the success of the change implementation.
25
When is the follow-up review date scheduled for this change?

Enter the scheduled date for the follow-up review.

To ensure that a review is conducted to assess the effectiveness of the change.

FAQs

The checklist covers change request initiation, risk assessment, impact analysis, approval processes, implementation planning, post-implementation review, and documentation of changes.

It includes items to verify the identification, documentation, investigation, root cause analysis, corrective and preventive action (CAPA) implementation, and trending of deviations.

Yes, the checklist is designed to audit change control processes for both minor and major changes, with specific sections addressing the different levels of scrutiny required for each.

It's recommended to conduct a comprehensive audit annually, with more frequent reviews of high-impact changes and critical deviations.

The audit team should typically include quality assurance personnel, change control coordinators, subject matter experts relevant to the changes being reviewed, and regulatory affairs specialists.

Benefits

Ensures comprehensive evaluation of change control and deviation management processes

Helps prevent unintended consequences of changes in manufacturing processes

Supports compliance with GMP requirements for change management and deviation handling

Enhances product quality and consistency through systematic control of changes

Facilitates continuous improvement and risk management in pharmaceutical operations