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Pharmaceutical Quality Management System (QMS) Audit Checklist

A comprehensive checklist for auditing the Quality Management System in pharmaceutical organizations to ensure regulatory compliance and continuous improvement

Pharmaceutical Quality Management System (QMS) Audit Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Quality Management System (QMS) Audit Checklist is a crucial tool for evaluating the effectiveness and compliance of a pharmaceutical company's quality management processes. This comprehensive checklist addresses key elements of a robust QMS, including quality policy and objectives, document control, change management, corrective and preventive actions (CAPA), and management review processes. By systematically assessing your QMS against regulatory requirements and industry best practices, you can identify areas for improvement, ensure consistent product quality, and maintain compliance with Good Manufacturing Practice (GMP) standards. Regular use of this checklist helps pharmaceutical organizations foster a culture of quality, drive continuous improvement, and demonstrate their commitment to producing safe and effective medicinal products.

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Industry

Pharmaceuticals

Standard

FDA Food Code, HACCP

Workspaces

Pharmaceutical manufacturing facilities
Corporate offices
R&D centers

Occupations

Quality Assurance Manager
Compliance Officer
Quality Systems Specialist
Regulatory Affairs Director
Operations Manager

Pharmaceutical Quality Management System Audit

(0 / 5)

1
What continuous improvement initiatives have been implemented in the QMS?

Provide details of initiatives.

Identify ongoing improvements for quality assurance.
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2
Is the Change Management process compliant with GMP?

Select compliance status.

Evaluate compliance of change management practices.
3
What is the audit score for document control processes?

Enter audit score (0-100).

Quantify the effectiveness of document control.
Min: 0
Target: 85
Max: 100
4
Describe the effectiveness of Corrective and Preventive Actions (CAPA) in the QMS.

Provide a detailed description.

Assess the effectiveness of CAPA processes.
5
Is the Pharmaceutical Quality Management System compliant with ICH Q10 standards?

Select compliance status.

Determine overall compliance with industry standards.
6
Is the risk management documentation readily available for review?

Select the availability status of documentation.

Check the accessibility of important risk management documentation.
7
Provide any suggestions for improving risk management processes.

Detail your suggestions for improvement.

Gather inputs for continuous improvement of risk management.
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8
What is the completion rate for risk management actions?

Enter completion rate percentage (0-100).

Assess the effectiveness of action completion related to risk management.
Min: 0
Target: 90
Max: 100
9
Has training on risk management been conducted for staff?

Indicate whether training has been conducted.

Ensure that staff are trained on risk management practices.
10
How frequently are risk assessments conducted in the QMS?

Select the frequency of risk assessments.

Evaluate the regularity of risk assessments for compliance.
11
What is the date of the last quality assurance review?

Enter the date of the last review.

Establish the timeliness of quality assurance activities.
12
Have quality metrics been reviewed in the last quarter?

Indicate if metrics have been reviewed.

Ensure that quality metrics are regularly monitored.
13
List any quality issues identified during the audit.

Provide a detailed description of quality issues.

Document quality issues to improve processes.
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14
What is the audit score for quality control processes?

Enter audit score (0-100).

Quantify the effectiveness of quality control measures.
Min: 0
Target: 88
Max: 100
15
Are the quality assurance processes compliant with GMP regulations?

Select the compliance status.

Assess compliance of quality assurance practices with regulations.
16
What is the date of the last training program review?

Enter the date of the last review.

Establish the timeliness of training program evaluations.
17
Provide feedback from staff regarding the training effectiveness.

Detail feedback from staff on training.

Gather insights to improve training programs.
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18
How often is a training needs assessment conducted?

Select the frequency of needs assessments.

Evaluate the regularity of assessing training needs.
19
What is the training completion rate for relevant staff?

Enter the completion rate percentage (0-100).

Quantify the percentage of staff who have completed mandatory training.
Min: 0
Target: 95
Max: 100
20
Is there a structured training program implemented for staff?

Indicate whether a training program is in place.

Ensure that staff receive the necessary training for compliance.
21
What is the date of the last supplier evaluation?

Enter the date of the last evaluation.

Establish the recency of supplier evaluations.
22
Summarize any feedback received from suppliers regarding quality expectations.

Provide a summary of supplier feedback.

Document supplier insights to improve quality management.
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23
Have supplier audits been conducted in the past year?

Indicate whether supplier audits were conducted.

Ensure that supplier audits are performed regularly.
24
What is the average score for supplier performance evaluations?

Enter the average evaluation score (0-100).

Quantify the performance of suppliers based on evaluations.
Min: 0
Target: 80
Max: 100
25
Are suppliers qualified according to the established criteria?

Select the compliance status of supplier qualifications.

Assess the compliance of supplier qualification processes.

FAQs

The checklist covers areas such as quality policy and objectives, document and record control, risk management, change control, deviation management, CAPA processes, and management review.

A comprehensive QMS audit should be conducted at least annually, with more frequent partial audits or self-assessments of specific QMS elements throughout the year.

The audit team should include quality assurance professionals, internal auditors, representatives from various departments (e.g., manufacturing, R&D, regulatory affairs), and potentially external consultants for an unbiased perspective.

The checklist helps identify strengths and weaknesses in the QMS, allowing the organization to prioritize improvement initiatives and track progress over time.

Yes, while the core QMS principles remain consistent, the checklist can be tailored to address specific requirements of different types of pharmaceutical operations, such as manufacturing, R&D, or distribution.

Benefits

Ensures comprehensive evaluation of the pharmaceutical quality management system

Helps identify gaps in QMS processes and opportunities for improvement

Supports compliance with GMP and other relevant regulatory standards

Facilitates consistent implementation of quality processes across the organization

Enhances overall product quality and patient safety