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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?

Please provide details about the document control procedure.

To ensure that all Quality Management System (QMS) documents are controlled and managed effectively.
2
Is the facility compliant with GMP standards?

Select compliance status.

To assess adherence to Good Manufacturing Practices which are critical for pharmaceutical quality.
3
What is the risk assessment score for the current processes?
To quantify the risk associated with the current processes in the QMS.
Min: 1
Target: 3
Max: 5
4
Describe the change control process in place.

Provide a detailed description of the change control process.

To evaluate how changes are managed within the QMS to ensure compliance and quality.
5
Are corrective and preventive actions (CAPA) effective?

Select effectiveness status.

To determine the effectiveness of the CAPA implemented in addressing quality issues.
6
When was the last internal audit conducted?

Select the date of the last internal audit.

To track the frequency of internal audits as part of the QMS.

7
Are training records for all personnel available and up to date?

Indicate if training records are available.

To ensure that all personnel are properly trained and qualified for their roles in the QMS.
8
Is the facility compliant with applicable regulatory standards?

Select compliance status.

To confirm that the facility adheres to relevant regulations, ensuring product quality and safety.
9
What is the current deviation rate for the past quarter?
To monitor the frequency of deviations and assess the effectiveness of the quality system.
Min: 0
Target: 5
Max: 100
10
Describe any quality improvement initiatives implemented in the last year.

Provide details of the quality improvement initiatives.

To evaluate the organization's commitment to continuous improvement in quality management.
11
When was the last management review of the QMS conducted?

Select the date of the last management review.

To ensure that management reviews occur regularly to assess the effectiveness of the QMS.
12
Has the supplier quality assessment been conducted?

Select assessment status.

To verify that suppliers meet quality standards and are regularly evaluated.

13
Is there a quality check process for raw materials before use?

Select the status of the raw material quality check process.

To ensure that only high-quality raw materials are utilized in production.
14
What is the failure rate for batch release testing over the last six months?
To assess the effectiveness of quality control measures during batch releases.
Min: 0
Target: 2
Max: 10
15
Describe any deviations or non-conformities identified in the last audit.

Provide detailed descriptions of any deviations or non-conformities.

To track and analyze quality issues that could impact product integrity.
16
When was the last quality control audit performed?

Select the date of the last quality control audit.

To maintain visibility on the frequency of quality control audits.
17
Is all product release documentation complete and signed off?

Indicate if product release documentation is complete.

To ensure that all necessary documentation for product release is completed appropriately.
18
Have customer complaints been reviewed and addressed?

Select the status of customer complaints review.

To confirm that customer feedback is considered for improving product quality.

19
Is all manufacturing equipment calibrated and maintained according to schedule?

Select the calibration status of manufacturing equipment.

To ensure that all equipment used in production is functioning correctly and producing quality products.
20
What is the production yield percentage for the last production cycle?
To evaluate the efficiency of the manufacturing process and identify areas for improvement.
Min: 0
Target: 95
Max: 100
21
Document any process deviations that occurred during the last production run.

Provide detailed descriptions of any process deviations.

To maintain a record of deviations for analysis and corrective action.
22
When was the last maintenance performed on manufacturing equipment?

Select the date of the last equipment maintenance.

To ensure that maintenance is performed regularly to avoid equipment failure and production loss.
23
Are all safety protocols being followed during the manufacturing process?

Indicate if safety protocols are being adhered to.

To ensure a safe working environment and compliance with safety regulations.
24
Is waste management compliant with regulatory standards?

Select the waste management compliance status.

To confirm that the facility is managing waste in accordance with environmental regulations.

25
Is the sterilization method validated and documented?

Select the validation status of the sterilization method.

To ensure that the sterilization process is effective and meets regulatory standards.
26
What is the duration of the sterilization cycle in minutes?
To ensure that the cycle duration meets the specifications for effective sterilization.
Min: 0
Target: 30
Max: 120
27
Describe how the sterilization process is monitored and recorded.

Provide details on monitoring and recording processes.

To ensure that there are adequate procedures in place for monitoring sterilization effectiveness.
28
When was the last review of the sterilization process conducted?

Select the date of the last sterilization process review.

To ensure that sterilization processes are reviewed regularly for compliance and effectiveness.
29
Are all personnel using appropriate personal protective equipment (PPE) during sterilization?

Indicate if PPE is being used by all personnel.

To ensure that safety protocols are followed to protect personnel during the sterilization process.
30
Have the environmental monitoring results been reviewed and found acceptable?

Select the status of environmental monitoring results.

To confirm that the environment where sterilization occurs is controlled and meets quality standards.

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

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