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Pharmaceutical Contract Manufacturing Organization (CMO) Audit Checklist

A comprehensive checklist for auditing Contract Manufacturing Organizations (CMOs) in the pharmaceutical industry to ensure regulatory compliance, product quality, and effective outsourcing partnerships.

Pharmaceutical Contract Manufacturing Organization (CMO) Audit Checklist
by: audit-now
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About This Checklist

Outsourcing pharmaceutical manufacturing to Contract Manufacturing Organizations (CMOs) requires rigorous oversight to ensure product quality, regulatory compliance, and supply chain integrity. This Pharmaceutical CMO Audit Checklist is a crucial tool for evaluating the capabilities, quality systems, and compliance status of CMOs. By systematically assessing manufacturing processes, quality control procedures, facility conditions, personnel qualifications, and regulatory compliance, this checklist helps maintain consistent product quality and regulatory adherence across external manufacturing partners. Regular implementation of this comprehensive audit process can significantly mitigate risks associated with outsourced manufacturing, enhance supply chain reliability, and support successful regulatory inspections.

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Industry

Pharmaceuticals

Standard

FDA Food Code, HACCP

Workspaces

Research laboratories

Occupations

Quality Assurance Auditor
Technical Operations Specialist
Supplier Quality Manager
Regulatory Affairs Manager
Contract Manufacturing Liaison

Quality Management System Audit

(0 / 5)

1
Please provide any additional comments on the quality management system.

Share any relevant comments or observations.

To gather qualitative insights regarding the effectiveness of the quality management system.
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2
Are all suppliers qualified according to regulatory standards?

Select the supplier qualification status.

To confirm that suppliers meet required quality and regulatory standards.
3
How often are personnel trained on GMP?

Enter the number of training sessions per year.

To ensure that staff are regularly updated on compliance requirements.
Min: 0
Target: 6
Max: 12
4
What corrective actions are in place for non-compliance?

Provide details of the corrective action plan.

To verify that appropriate measures are taken for any non-compliance issues.
5
Is the facility compliant with GMP regulations?

Select the compliance status.

To ensure adherence to Good Manufacturing Practices.
6
What action plan is in place to address non-conformance issues?

Detail the action plan for addressing non-conformance.

To ensure that there is a proactive approach to managing compliance issues.
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7
How many non-conformance reports were issued in the last year?

Enter the total number of non-conformance reports.

To evaluate the frequency of compliance issues.
Min: 0
Target: 0
8
Is there a compliance training program in place for all employees?

Indicate whether a compliance training program exists.

To ensure employees are trained on regulatory requirements.
9
When was the last regulatory inspection conducted?

Enter the date of the last inspection.

To maintain an accurate record of inspection timelines.
10
What was the outcome of the last regulatory inspection?

Select the outcome of the last inspection.

To assess the facility's standing with regulatory bodies.
11
Please provide any additional comments regarding the supplier's performance.

Share any relevant comments or insights.

To gather qualitative feedback on the supplier's overall performance.
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12
Have corrective actions been implemented for previous quality issues?

Indicate whether corrective actions have been implemented.

To ensure that past quality issues are being addressed effectively.
13
When was the last quality audit conducted for this supplier?

Enter the date of the last quality audit.

To keep track of the audit cycles and supplier evaluation.
14
What is the defect rate percentage of the supplier's products?

Enter the defect rate as a percentage.

To evaluate the supplier's performance in terms of product quality.
Min: 0
Target: 2
Max: 100
15
How would you rate the quality of the supplier's products?

Select the quality rating for the supplier.

To assess the supplier's ability to meet quality standards.
16
Describe any issues encountered during the manufacturing process.

Provide details of any manufacturing issues.

To identify potential areas for improvement in the manufacturing process.
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17
When was the last review of the manufacturing process conducted?

Enter the date of the last process review.

To track the frequency of process evaluations.
18
Are all manufacturing equipment calibrated regularly?

Indicate whether equipment is calibrated regularly.

To ensure that equipment accuracy is maintained.
19
What is the average batch size produced?

Enter the average batch size in units.

To monitor production capacity and efficiency.
Min: 1
Target: 1000
20
Is the manufacturing process validated according to regulatory standards?

Select the validation status of the manufacturing process.

To ensure that the manufacturing process meets validation requirements.
21
Please provide any additional comments on laboratory safety practices.

Share any relevant comments or observations.

To gather qualitative feedback regarding safety practices in the laboratory.
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22
Are emergency procedures clearly posted in the laboratory?

Indicate whether emergency procedures are posted.

To ensure that all personnel are aware of emergency procedures.
23
When was the last safety training conducted for laboratory personnel?

Enter the date of the last safety training.

To ensure that personnel are regularly trained on safety procedures.
24
How many safety violations were reported in the last year?

Enter the total number of safety violations.

To evaluate the effectiveness of safety protocols in the laboratory.
Min: 0
Target: 0
25
Is the laboratory compliant with safety regulations?

Select the safety compliance status of the laboratory.

To ensure that laboratory practices adhere to safety standards.

FAQs

CMO audits should be conducted before initiating a contract (qualification audit), annually thereafter, and additionally when there are significant changes in processes, facilities, or key personnel. More frequent audits may be necessary for high-risk products or CMOs with compliance issues.

This checklist covers quality management systems, manufacturing processes and controls, facility and equipment qualification, material management, laboratory controls, personnel training and qualifications, data integrity practices, change control procedures, and compliance with applicable regulations.

These audits are typically conducted by quality assurance auditors, technical operations specialists, or third-party auditors with expertise in pharmaceutical manufacturing regulations and quality systems.

The checklist ensures that the CMO meets all relevant GMP regulations and quality standards, including those of FDA, EMA, and other applicable regulatory bodies, which is crucial for maintaining the sponsor's compliance status and product quality.

If significant non-conformities are identified, actions should include immediate risk assessment of impact on product quality, development of a corrective action plan with the CMO, increased oversight or monitoring, potential adjustment of manufacturing agreements, and in severe cases, consideration of alternative CMOs. All findings and actions must be thoroughly documented and followed up.

Benefits

Ensures CMO compliance with GMP regulations and sponsor quality requirements

Reduces risks associated with outsourced pharmaceutical manufacturing

Improves consistency and quality of products across different manufacturing sites

Enhances transparency and communication between sponsors and CMOs

Facilitates early identification of potential quality or compliance issues