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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

Healthcare

Standard

Food Safety Standards

Workspaces

Research Facilities

Occupations

Quality Assurance Auditor
Technical Operations Specialist
Supplier Quality Manager
Regulatory Affairs Manager
Contract Manufacturing Liaison
1
Is the facility compliant with GMP regulations?
2
What corrective actions are in place for non-compliance?
3
How often are personnel trained on GMP?
Min: 0
Target: 6
Max: 12
4
Are all suppliers qualified according to regulatory standards?
5
Please provide any additional comments on the quality management system.
6
What was the outcome of the last regulatory inspection?
7
When was the last regulatory inspection conducted?
8
Is there a compliance training program in place for all employees?
9
How many non-conformance reports were issued in the last year?
Min: 0
Target: 0
10
What action plan is in place to address non-conformance issues?
11
How would you rate the quality of the supplier's products?
12
What is the defect rate percentage of the supplier's products?
Min: 0
Target: 2
Max: 100
13
When was the last quality audit conducted for this supplier?
14
Have corrective actions been implemented for previous quality issues?
15
Please provide any additional comments regarding the supplier's performance.
16
Is the manufacturing process validated according to regulatory standards?
17
What is the average batch size produced?
Min: 1
Target: 1000
18
Are all manufacturing equipment calibrated regularly?
19
When was the last review of the manufacturing process conducted?
20
Describe any issues encountered during the manufacturing process.
21
Is the laboratory compliant with safety regulations?
22
How many safety violations were reported in the last year?
Min: 0
Target: 0
23
When was the last safety training conducted for laboratory personnel?
24
Are emergency procedures clearly posted in the laboratory?
25
Please provide any additional comments on laboratory safety practices.

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 of Pharmaceutical Contract Manufacturing Organization (CMO) Audit Checklist

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