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Pharmaceutical Quality Management System (QMS) Audit Checklist

A comprehensive checklist for auditing pharmaceutical quality management systems, covering quality policy, risk management, change control, CAPA processes, and continuous improvement initiatives to ensure regulatory compliance and operational excellence.

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, risk management, change control, corrective and preventive actions (CAPA), and continuous improvement initiatives. By systematically assessing the QMS, pharmaceutical organizations can ensure adherence to regulatory requirements, enhance product quality and safety, and foster a culture of quality throughout the organization. This checklist helps identify gaps in quality processes, ultimately contributing to improved operational efficiency and regulatory compliance.

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Industry

Pharmaceuticals

Standard

FDA Food Code, HACCP

Workspaces

Pharmaceutical Company Headquarters and Manufacturing Sites

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
QMS Auditor
Compliance Officer
Operations Manager

Quality Management System Audit

(0 / 4)

1
Is the organization compliant with applicable regulatory requirements?

Select regulatory compliance status.

To assess the organization's compliance with regulations.
2
What is the frequency of risk assessments conducted?

Enter frequency in months.

To evaluate the regularity of risk assessments for compliance.
Min: 1
Target: Monthly
Max: 12
3
Is there a documented change control process in place?

Indicate whether a documented change control process exists.

To verify if the change control process is established and documented.
4
Is the Corrective and Preventive Action (CAPA) process being followed as per the QMS requirements?

Select compliance status.

To ensure adherence to the CAPA process for continuous improvement.
5
Has the management review been conducted as per the QMS requirements?

Select the management review status.

To verify compliance with QMS management review processes.
6
How many non-conformances were identified during this audit?

Enter the number of non-conformances.

To quantify the issues found and assess areas for improvement.
Min: 0
Target: 0
Max: 100
7
When was the last audit conducted?

Select the date of the last audit.

To track the frequency of audits and ensure timely reviews.
8
Please provide a summary of the key findings from the audit.

Enter a summary of audit findings.

To document important insights and observations from the audit process.
Write something awesome...
9
List any continuous improvement initiatives implemented in the last year.

Describe the continuous improvement initiatives.

To capture efforts made towards improving the quality management system.
Write something awesome...
10
What is the closure rate of CAPA actions within the last year?

Enter the closure rate percentage.

To evaluate the effectiveness of the CAPA process in resolving issues.
Min: 0
Target: 90
Max: 100
11
How frequently are internal audits conducted?

Select the frequency of internal audits.

To assess the regularity of internal audits as part of the QMS.
12
Is there a training program in place for employees on the QMS?

Indicate whether a training program exists.

To determine if employees are adequately trained in quality management system procedures.
13
Provide any feedback received from stakeholders regarding the QMS.

Enter stakeholder feedback.

To gather insights from stakeholders to improve the QMS.
Write something awesome...
14
What is the severity level of the non-conformances identified in the audit?

Select the severity level of identified non-conformances.

To evaluate the impact of non-conformances on the QMS.
15
What percentage of documents are controlled and up to date?

Enter the percentage of controlled and up-to-date documents.

To assess the effectiveness of document control within the QMS.
Min: 0
Target: 95
Max: 100
16
When was the last review of the Quality Management System conducted?

Select the date of the last QMS review.

To ensure that the QMS is reviewed regularly as part of compliance.
17
What recommendations can be made to enhance risk management in the QMS?

Provide risk assessment recommendations.

To gather suggestions for improving risk management processes.
Write something awesome...
18
What is the status of the risk mitigation measures implemented?

Select the status of risk mitigation measures.

To assess the effectiveness of risk mitigation actions.
19
How many risks have been identified in the current risk assessment?

Enter the number of identified risks.

To quantify the risks that could impact the QMS.
Min: 0
Target: 5
Max: 100
20
Is there a documented risk management plan in place for the QMS?

Indicate whether a risk management plan exists.

To verify that a systematic approach to risk management is established.

FAQs

The checklist covers various aspects of a QMS including quality policy and objectives, document control, risk management, change control, CAPA processes, management review, and quality metrics.

By ensuring a comprehensive evaluation of the QMS, this checklist helps pharmaceutical companies maintain compliance with regulatory requirements such as FDA cGMP, EU GMP, and ICH guidelines.

This checklist is designed for use by quality assurance managers, regulatory affairs specialists, internal auditors, and senior management in pharmaceutical companies, as well as external auditors and regulatory inspectors.

QMS audits should be conducted at least annually, with more frequent partial audits of specific QMS elements throughout the year. Additionally, audits should be performed after significant organizational changes or in response to major quality issues.

Yes, the checklist can be adapted for various pharmaceutical operations including drug manufacturing, research and development, clinical trials, and distribution, ensuring comprehensive coverage across different aspects of the pharmaceutical industry.

Benefits

Ensures compliance with ICH Q10 and other relevant quality management standards

Improves overall product quality and consistency

Enhances risk management and decision-making processes

Facilitates continuous improvement of pharmaceutical operations

Streamlines regulatory inspections and reduces compliance-related issues