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Pharmaceutical Stability Testing Audit Checklist

A comprehensive checklist for auditing stability testing processes in pharmaceutical research and development to ensure product quality, regulatory compliance, and accurate shelf-life determination.

Pharmaceutical Stability Testing Audit Checklist

by: audit-now
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About This Checklist

Stability testing is a crucial aspect of pharmaceutical product development and quality assurance. This Pharmaceutical Stability Testing Audit Checklist is an indispensable tool for evaluating the integrity and effectiveness of stability testing programs. By systematically assessing test protocols, storage conditions, analytical methods, and data management practices, this checklist helps ensure compliance with regulatory requirements and maintains the highest standards of product quality and safety. Regular implementation of this comprehensive audit process can significantly enhance the reliability of stability data, improve product shelf-life predictions, and support informed decision-making in pharmaceutical development and manufacturing.

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Industry

Healthcare

Standard

Pharmaceutical Stability and Quality Standards

Workspaces

Research Facilities

Occupations

Quality Assurance Specialist
Stability Testing Coordinator
Analytical Chemist
Regulatory Affairs Manager
Formulation Scientist
1
Is the stability protocol being followed as per ICH guidelines?

Select the compliance status.

To ensure adherence to established protocols for stability testing.
2
What is the determined shelf-life of the product?

Enter shelf-life in months.

To assess the product's stability and ensure it meets regulatory standards.
Min: 0
Target: 12
Max: 60
3
Describe the storage conditions for the stability samples.

Provide details on temperature, humidity, and light exposure.

To verify that samples are stored under conditions that do not affect stability.
4
Is there a regular check for data integrity in stability testing data?

Indicate whether data integrity checks are performed.

To confirm that data manipulation or loss is prevented.
5
Are the analytical methods used for stability testing validated?

Select the validation status.

To ensure the reliability of the methods used in testing.
6
What was the date of the last stability test conducted?

Select the date of the last test.

To ensure that stability tests are performed within the required frequency.
7
Has a degradation assessment been performed on the product?

Select the assessment status.

To confirm that potential degradation issues are identified and managed.
8
Please provide any observations noted during the stability testing.

Enter observations, if any.

To gather qualitative data that may affect product stability.
9
What is the temperature maintained during stability testing?

Enter temperature in degrees Celsius.

To verify that temperature conditions are controlled as per specifications.
Min: 15
Target: 25
Max: 30
10
Is the stability testing compliant with regulatory requirements?

Select the compliance status.

To ensure compliance with ICH and FDA regulations.
11
Are the criteria for sample selection documented and followed?

Select the status of sample selection criteria.

To ensure that the sample selection is consistent and meets the testing requirements.
12
What are the humidity levels maintained during stability testing?

Enter humidity level in percentage.

To verify that humidity conditions are controlled as per specifications.
Min: 30
Target: 45
Max: 60
13
Are the testing equipment and instruments calibrated regularly?

Provide details about the calibration schedule.

To confirm that all equipment used in testing is functioning accurately.
14
Have any adverse conditions been reported during stability testing?

Indicate whether any adverse conditions have been observed.

To identify any issues that could affect product stability.
15
What is the date for the next scheduled stability test?

Select the date for the next test.

To ensure timely follow-up on stability assessments.
16
Is the frequency of stability testing in accordance with regulatory guidelines?

Select the frequency compliance status.

To ensure that stability testing is conducted at the required intervals.
17
Describe the methodology used for stability testing.

Provide a detailed description of the methodology.

To ensure that the testing methodology is appropriate and documented.
18
What is the storage duration for the stability samples?

Enter storage duration in months.

To confirm that samples are stored for the correct amount of time to assess stability.
Min: 1
Target: 24
Max: 36
19
Has a stability report been generated for the completed tests?

Indicate whether a stability report has been generated.

To confirm that results from stability tests are documented and available for review.
20
When was the stability data last reviewed?

Select the last review date.

To ensure that stability data is regularly reviewed for compliance and accuracy.
21
Is all documentation related to stability testing complete and accurate?

Select the documentation status.

To ensure that all necessary documentation is present for regulatory compliance.
22
What is the sample size used for stability testing?

Enter the number of samples tested.

To verify that the sample size meets the specified requirements for reliable results.
Min: 10
Target: 30
Max: 100
23
Are training records for personnel involved in stability testing up to date?

Indicate whether training records are current.

To ensure that all personnel are properly trained in stability testing procedures.
24
What quality control measures are implemented during stability testing?

Provide details of the quality control measures.

To assess the effectiveness of quality control practices in place.
25
When is the next review scheduled for the stability testing protocols?

Select the date for the next review.

To ensure that stability testing protocols are regularly reviewed for relevance and accuracy.

FAQs

Stability testing audits should be conducted at least annually, or more frequently when introducing new products, changing formulations, or addressing stability concerns.

This checklist covers stability test protocols, storage conditions, analytical methods validation, data integrity, documentation practices, and adherence to ICH guidelines and regulatory requirements.

These audits are typically conducted by quality assurance specialists, stability testing coordinators, or regulatory affairs professionals with expertise in pharmaceutical stability requirements.

The checklist ensures that all aspects of stability testing meet regulatory standards, including study design, data collection, analysis methods, and reporting, which are crucial for compliance with ICH guidelines and regulatory submissions.

If unexpected degradation is observed, actions should include investigating the root cause, evaluating the impact on product quality and safety, potentially adjusting storage conditions or packaging, and considering reformulation if necessary. All findings and actions must be thoroughly documented.

Benefits of Pharmaceutical Stability Testing Audit Checklist

Ensures compliance with ICH guidelines and regulatory requirements for stability testing

Improves accuracy and reliability of stability data for pharmaceutical products

Enhances product quality assurance and shelf-life predictions

Reduces risks associated with product degradation and expiration

Facilitates efficient regulatory submissions and approvals