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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, operational excellence, and continuous improvement.

Pharmaceutical Quality Management System (QMS) Audit Checklist

by: audit-now
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About This Checklist

A robust Quality Management System (QMS) is the backbone of pharmaceutical operations, ensuring consistent product quality, regulatory compliance, and continuous improvement. This Pharmaceutical Quality Management System Audit Checklist is a comprehensive tool for evaluating the effectiveness and compliance of a company's QMS. By systematically assessing quality policies, procedures, documentation, risk management, and continuous improvement processes, this checklist helps identify gaps, ensure regulatory adherence, and drive quality excellence throughout the organization. Regular implementation of this audit process can significantly enhance overall quality performance, streamline operations, and foster a culture of quality in pharmaceutical manufacturing and research.

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Industry

Healthcare

Standard

Food Safety Standards

Workspaces

Research Facilities

Occupations

Quality Assurance Manager
Compliance Officer
Operations Director
Regulatory Affairs Specialist
Internal Auditor
1
Is there a documented procedure for document control?
2
Is the facility compliant with GMP standards?
3
What is the risk assessment score for the current processes?
Min: 1
Target: 3
Max: 5
4
Describe the change control process in place.
5
Are corrective and preventive actions (CAPA) effective?
6
When was the last internal audit conducted?
7
Are training records for all personnel available and up to date?
8
Is the facility compliant with applicable regulatory standards?
9
What is the current deviation rate for the past quarter?
Min: 0
Target: 5
Max: 100
10
Describe any quality improvement initiatives implemented in the last year.
11
When was the last management review of the QMS conducted?
12
Has the supplier quality assessment been conducted?
13
Is there a quality check process for raw materials before use?
14
What is the failure rate for batch release testing over the last six months?
Min: 0
Target: 2
Max: 10
15
Describe any deviations or non-conformities identified in the last audit.
16
When was the last quality control audit performed?
17
Is all product release documentation complete and signed off?
18
Have customer complaints been reviewed and addressed?
19
Is all manufacturing equipment calibrated and maintained according to schedule?
20
What is the production yield percentage for the last production cycle?
Min: 0
Target: 95
Max: 100
21
Document any process deviations that occurred during the last production run.
22
When was the last maintenance performed on manufacturing equipment?
23
Are all safety protocols being followed during the manufacturing process?
24
Is waste management compliant with regulatory standards?
25
Is the sterilization method validated and documented?
26
What is the duration of the sterilization cycle in minutes?
Min: 0
Target: 30
Max: 120
27
Describe how the sterilization process is monitored and recorded.
28
When was the last review of the sterilization process conducted?
29
Are all personnel using appropriate personal protective equipment (PPE) during sterilization?
30
Have the environmental monitoring results been reviewed and found acceptable?

FAQs

A comprehensive QMS audit should be conducted at least annually. However, specific elements of the QMS may be audited more frequently based on risk assessment and regulatory requirements.

This checklist covers quality policy and objectives, document and record control, risk management processes, change control procedures, corrective and preventive actions (CAPA), management review, internal audit processes, and continuous improvement initiatives.

QMS audits are typically conducted by senior quality assurance professionals, internal auditors, or external consultants with expertise in pharmaceutical quality systems and regulatory requirements.

The checklist ensures that all aspects of the QMS align with regulatory standards, including documentation practices, risk management, change control, and continuous improvement processes, which are crucial for compliance with GMP and other industry regulations.

If significant non-conformities are identified, actions should include immediate documentation of findings, root cause analysis, development and implementation of a corrective action plan, follow-up verification of effectiveness, and potential updates to QMS processes. All actions must be thoroughly documented and reviewed by management.

Benefits of Pharmaceutical Quality Management System (QMS) Audit Checklist

Ensures comprehensive compliance with GMP and international quality standards

Identifies gaps and opportunities for improvement in quality processes

Enhances overall organizational efficiency and effectiveness

Reduces quality-related risks and associated costs

Promotes a culture of continuous improvement and quality excellence