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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

Healthcare

Standard

Food Safety Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
QMS Auditor
Compliance Officer
Operations Manager
1
Is the Corrective and Preventive Action (CAPA) process being followed as per the QMS requirements?
2
Is there a documented change control process in place?
3
What is the frequency of risk assessments conducted?
Min: 1
Target: Monthly
Max: 12
4
Is the organization compliant with applicable regulatory requirements?
5
Please provide a summary of the key findings from the audit.
6
When was the last audit conducted?
7
How many non-conformances were identified during this audit?
Min: 0
Target: 0
Max: 100
8
Has the management review been conducted as per the QMS requirements?
9
Is there a training program in place for employees on the QMS?
10
How frequently are internal audits conducted?
11
What is the closure rate of CAPA actions within the last year?
Min: 0
Target: 90
Max: 100
12
List any continuous improvement initiatives implemented in the last year.
13
When was the last review of the Quality Management System conducted?
14
What percentage of documents are controlled and up to date?
Min: 0
Target: 95
Max: 100
15
What is the severity level of the non-conformances identified in the audit?
16
Provide any feedback received from stakeholders regarding the QMS.
17
Is there a documented risk management plan in place for the QMS?
18
How many risks have been identified in the current risk assessment?
Min: 0
Target: 5
Max: 100
19
What is the status of the risk mitigation measures implemented?
20
What recommendations can be made to enhance risk management in the QMS?

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 of Pharmaceutical Quality Management System (QMS) Audit Checklist

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