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Pharmaceutical Stability Testing Program Audit Checklist

A comprehensive checklist for auditing pharmaceutical stability testing programs to ensure compliance with ICH guidelines, data integrity, and accurate shelf-life determination in drug development and manufacturing.

Pharmaceutical Stability Testing Program Audit Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Stability Testing Program Audit Checklist is an essential tool for ensuring the robustness and compliance of stability studies in pharmaceutical development and manufacturing. This comprehensive checklist addresses key aspects of stability testing, from study design to data analysis and reporting, helping to maintain product quality and shelf-life accuracy. By implementing this checklist, pharmaceutical companies can enhance their stability testing practices, meet regulatory requirements, and ensure the consistent quality and efficacy of their products throughout their intended storage period.

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Industry

Pharmaceuticals

Standard

ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Workspaces

Clinical trial sites

Occupations

Stability Scientist
Quality Control Analyst
Regulatory Affairs Specialist
Formulation Scientist
Quality Assurance Manager

Stability Testing Compliance

(0 / 4)

1
Please provide any notes related to regulatory compliance issues encountered.

Enter notes here.

To document any compliance issues that may affect stability testing outcomes.
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2
Was an appropriate method used for stability data analysis?

Select the analysis method compliance status.

To confirm that the analysis method meets industry standards.
3
What is the determined shelf-life of the product (in months)?

Enter shelf-life in months.

To verify that the shelf-life determination aligns with the product's stability data.
Min: 0
Target: 24
Max: 60
4
Does the stability study design comply with ICH Q1A(R2) requirements?

Select compliance status.

To ensure that the stability study is designed in accordance with regulatory standards.
5
Are the sample handling procedures compliant with ICH guidelines?

Select compliance status.

To ensure that sample handling is performed according to established standards to avoid contamination or degradation.
6
What is the start date of the stability testing?

Select the start date.

To track the duration of the stability study and ensure timely evaluation.
7
What is the monitored humidity level during the stability test (in %)?

Enter humidity level in percentage.

To verify that humidity levels are kept within acceptable limits during stability testing.
Min: 20
Target: 50
Max: 80
8
Is the temperature control during stability testing within the specified range?

Select compliance status.

To ensure that temperature conditions are maintained to guarantee accurate stability testing results.
9
How many deviations were recorded during the stability testing process?

Enter the number of deviations.

To track deviations that may impact the integrity of the stability study.
Min: 0
Target: 0
Max: 100
10
What is the date when the stability testing documentation was last reviewed?

Select the review date.

To ensure that documentation is regularly reviewed for compliance and accuracy.
11
Is the stability report available for review?

Select the availability status.

To ensure that the stability report is accessible for regulatory and quality assurance purposes.
12
Describe the adequacy of the study protocol used for stability testing.

Provide a detailed description.

To assess whether the protocol adequately covers all necessary aspects of the stability testing process.
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13
Please provide any notes related to equipment performance during stability testing.

Enter notes here.

To document any performance issues that may affect testing outcomes.
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14
Is there a maintenance log available for the stability testing equipment?

Select if the maintenance log is available.

To confirm that regular maintenance is performed and documented, ensuring equipment reliability.
15
What is the accuracy of the temperature measurement in the testing equipment (in °C)?

Enter accuracy in degrees Celsius.

To verify that the temperature measurement meets the required accuracy specifications.
Min: 0
Target: 0.5
Max: 2
16
Is the stability testing equipment calibrated and within its calibration date?

Select calibration status.

To ensure that the equipment used for stability testing provides accurate and reliable results.
17
What is the date for the next risk review of the stability study?

Select the next review date.

To ensure that risks are regularly reviewed and managed throughout the stability study duration.
18
How many risk factors have been identified for the stability study?

Enter the number of identified risk factors.

To track the number of potential risks that may affect stability outcomes.
Min: 0
Target: 0
Max: 50
19
What mitigation strategies are in place for identified risks?

Provide detailed mitigation strategies.

To ensure that there are effective strategies to mitigate risks associated with the stability study.
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20
What is the assessed risk level of the stability study?

Select the risk level.

To evaluate the potential risks associated with the stability study that may impact product quality.

FAQs

The checklist covers key areas such as stability study design, sample selection and handling, storage condition monitoring, analytical method suitability, data collection and analysis, out-of-specification investigations, and stability report preparation.

Stability testing program audits should be conducted at least annually, with more frequent audits for new product developments or in preparation for regulatory inspections.

Stability testing program audits are typically conducted by internal quality assurance personnel, stability experts, or external consultants with expertise in pharmaceutical stability studies and regulatory requirements.

Non-compliance issues can lead to unreliable stability data, inaccurate shelf-life determinations, regulatory submission delays, product recalls due to stability failures, and potential regulatory actions affecting product approvals or marketing authorizations.

By ensuring robust stability testing practices, this checklist helps accurately determine product shelf life, storage conditions, and expiration dates, thereby maintaining product quality and efficacy throughout the supply chain and enhancing patient safety.

Benefits

Ensures compliance with ICH Q1A(R2) guidelines for stability testing

Improves accuracy in determining product shelf life and storage conditions

Enhances the reliability of stability data for regulatory submissions

Supports early detection of potential formulation or packaging issues

Facilitates consistent stability testing practices across multiple products and sites