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Pharmaceutical Packaging and Labeling Compliance Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical packaging and labeling compliance, ensuring regulatory adherence, and maintaining the highest standards of product quality and patient safety through proper packaging and labeling practices.

Pharmaceutical Packaging and Labeling Compliance Audit Checklist

by: audit-now
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About This Checklist

Packaging and labeling play a crucial role in ensuring the safety, efficacy, and proper use of pharmaceutical products. This Packaging and Labeling Compliance Audit Checklist is designed to comprehensively evaluate the adherence to regulatory requirements and industry best practices in pharmaceutical packaging and labeling processes. By systematically assessing material selection, design controls, printing processes, packaging line operations, and labeling accuracy, this checklist helps identify potential compliance gaps, mitigate risks of packaging and labeling errors, and maintain the highest standards of product quality and patient safety. Regular use of this checklist supports regulatory compliance, reduces the risk of product recalls, and enhances overall packaging and labeling integrity in pharmaceutical manufacturing.

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Industry

Healthcare

Standard

Pharmaceutical Quality and Integrity Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Packaging Managers
Quality Assurance Specialists
Regulatory Affairs Managers
Packaging Engineers
Labeling Compliance Officers
1
Is the drug labeling compliant with EU Falsified Medicines Directive?

Select the compliance status.

To ensure that the labeling meets legal standards for safety and information.
2
What is the thickness of the primary packaging material?

Enter the thickness in micrometers.

To ensure that the material specifications meet the required standards.
Min: 10
Target: 50
Max: 100
3
Has the artwork for packaging been approved?

Indicate whether the artwork has been approved.

To confirm that the packaging artwork has passed the necessary approvals.
4
Is the serialization on the packaging compliant with regulations?

Select the serialization compliance status.

To verify that serialization is being applied as per the required standards.
5
Is the product labeling available in the required languages?

Select the availability status of multilingual labeling.

To ensure that all necessary languages are included for consumer understanding.
6
What is the date of the last packaging line clearance?

Enter the last clearance date in YYYY-MM-DD format.

To ensure that the packaging line is clear and ready for use, preventing contamination.
7
Provide a summary of the stability testing results for packaged products.

Summarize the stability testing results here.

To document the stability of the products post-packaging and ensure quality.
8
What is the date of the artwork approval?

Enter the artwork approval date.

To track when the packaging artwork was officially approved.
9
Are the anti-counterfeiting measures implemented on the packaging?

Select the status of anti-counterfeiting measures.

To verify that necessary anti-counterfeiting measures are in place to protect consumers.
10
What is the percentage of labeling accuracy achieved?

Enter the percentage value.

To assess the accuracy of the labeling process and compliance with standards.
Min: 90
Target: 98
Max: 100
11
When was the last compliance audit conducted for packaging?

Enter the date of the last compliance audit.

To track the frequency of compliance audits and ensure ongoing regulatory adherence.
12
Is the packaging material compliant with FDA regulations?

Indicate whether the packaging material is compliant.

To ensure that the materials used in packaging are safe and compliant.
13
Does the labeling adhere to ICH Q1A(R2) guidelines?

Select the compliance status.

To ensure that the labeling meets international guidelines for quality and safety.
14
Describe the setup process for the packaging line.

Provide details about the setup process.

To ensure that the packaging line is set up correctly for production to avoid errors.
15
What is the average throughput rate of the packaging line?

Enter the throughput rate in units per hour.

To monitor the efficiency of the packaging process.
Min: 100
Target: 300
Max: 500
16
Provide a summary of the quality control findings during packaging.

Summarize the quality control findings here.

To document any quality control issues and actions taken to resolve them.
17
Is the packaging material certified as safe for use?

Select the safety status of the packaging material.

To confirm that the materials used in packaging are safe and comply with health regulations.
18
Document any labeling errors encountered during the packaging process.

Provide details of any labeling errors or issues.

To track and address any labeling errors that could impact compliance.
19
When is the next scheduled audit for packaging compliance?

Enter the date of the next scheduled audit.

To ensure that regular audits are planned to maintain compliance standards.
20
What is the font size used on the packaging labels?

Enter the font size in points.

To ensure that the font size meets regulatory requirements for visibility.
Min: 8
Target: 12
Max: 14

FAQs

The checklist covers packaging material specifications, artwork and labeling content approval processes, packaging line clearance procedures, in-process controls, serialization and anti-counterfeiting measures, and stability testing of packaged products.

Comprehensive audits should be conducted at least annually, with more frequent checks on critical processes or when significant changes are made to packaging materials or labeling content.

The audit team should include quality assurance specialists, packaging engineers, regulatory affairs experts, and representatives from manufacturing and marketing to ensure all aspects of packaging and labeling are thoroughly evaluated.

The checklist includes specific sections on multilingual labeling compliance, including translation accuracy, space allocation on packaging, and regulatory requirements for different markets.

Yes, the checklist is designed to be adaptable for various packaging types, including blister packs, bottles, vials, and combination products, while maintaining core compliance principles.

Benefits

Ensures compliance with global packaging and labeling regulations

Reduces the risk of packaging-related product quality issues and recalls

Enhances patient safety through accurate and clear labeling

Optimizes packaging line efficiency and reduces errors

Supports consistent brand representation and product identification