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Pharmaceutical Stability Testing Audit Checklist

A comprehensive checklist for auditing pharmaceutical stability testing programs, covering study design, sample storage, analytical methods, and data interpretation to ensure compliance with regulatory requirements and maintain product quality.

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

The Pharmaceutical Stability Testing Audit Checklist is a crucial tool for ensuring the quality, safety, and efficacy of pharmaceutical products throughout their shelf life. This comprehensive checklist addresses key aspects of stability testing programs, including study design, sample storage conditions, analytical methods, and data interpretation. By systematically evaluating stability testing procedures, pharmaceutical companies can maintain compliance with regulatory requirements, optimize product formulations, and make informed decisions about storage conditions and expiration dating. This checklist helps identify potential issues in stability testing processes, ensuring the reliability of stability data and ultimately contributing to patient safety and product quality.

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Industry

Healthcare

Standard

ICH Q1A - Stability Testing

Workspaces

Pharmaceutical Facilities

Occupations

Stability Program Manager
Quality Control Analyst
Regulatory Affairs Specialist
Pharmaceutical Auditor
Formulation Scientist

1
Is the stability testing conducted in accordance with ICH Q1A(R2) guidelines?

Select compliance status.

To ensure that the testing meets regulatory standards.
2
What is the determined shelf life of the product?

Enter the shelf life in months.

To assess the product's stability and marketability.
Min: 0
Target: 12
Max: 60
3
Please provide a summary of the stability data collected.

Enter a brief summary of the stability data.

To document the results of the stability tests.
4
What is the date of the stability testing?

Select the date of the test.

To track when stability testing was performed.
5
Is the expiration dating compliant with ICH guidelines?

Select compliance status.

To ensure regulatory compliance in product labeling.
6
Describe the methodology used for stability testing.

Provide a detailed description of the testing methodology.

To ensure clarity and consistency in testing procedures.
7
What is the temperature control range maintained during testing?

Enter the temperature range in degrees Celsius.

To verify that stability testing conditions are within specified limits.
Min: 15
Target: 25
Max: 30
8
Are the humidity levels during testing compliant with established guidelines?

Select humidity compliance status.

To ensure environmental conditions meet testing requirements.
9
When was the last calibration of stability testing equipment performed?

Select the date of the last calibration.

To ensure that testing equipment is properly calibrated for accurate results.
10
Is all testing documentation complete and available?

Confirm if documentation is complete.

To ensure that all necessary records are maintained for compliance.
11
Is the testing frequency compliant with ICH guidelines?

Select compliance status for testing frequency.

To ensure that stability tests are performed at the required intervals.
12
Provide the identification details of the stability samples used.

Enter identification details of the stability samples.

To maintain traceability of the samples tested.
13
What is the measured pH level of the product during testing?

Enter the pH level.

To ensure the pH level is within acceptable limits for stability.
Min: 4
Target: 7
Max: 10
14
What is the start date and time of the stability testing?

Select the start date and time of the test.

To record when the stability testing commenced.
15
Document any observations made during stability testing.

Provide detailed observation notes.

To capture any anomalies or important notes during testing.
16
Has the raw data from stability testing been reviewed?

Confirm if the raw data review is complete.

To ensure that all data is verified for accuracy before final analysis.
17
Describe the conditions under which the stability tests were conducted.

Enter a description of the test conditions.

To provide context and ensure replicability of the testing conditions.
18
What is the number of samples tested for stability?

Enter the number of samples tested.

To ensure that the sample size is sufficient for statistical validity.
Min: 1
Target: 30
Max: 100
19
Is the testing environment compliant with established protocols?

Select compliance status for the testing environment.

To verify that environmental conditions meet required standards.
20
When is the next scheduled review of the stability data?

Select the date for the next review.

To ensure timely follow-up on stability testing results.
21
Document any deviations from the established testing protocol.

Provide details of any protocol deviations.

To ensure transparency and traceability of any changes made during testing.
22
What temperature was maintained during the storage of stability samples?

Enter the storage temperature in degrees Celsius.

To confirm that storage conditions align with stability testing requirements.
Min: 15
Target: 25
Max: 30
23
Are the stability test results compliant with specifications?

Select compliance status for the test results.

To verify that the test results meet the established criteria for product quality.
24
What is the date and time when stability testing was completed?

Select the date and time of test completion.

To record the completion of the stability testing phase.
25
Enter any comments from the reviewer regarding the stability testing.

Provide any reviewer comments here.

To capture feedback and insights from the review process.

FAQs

Yes, the checklist can be adapted for various pharmaceutical dosage forms including solid oral dosage forms, liquids, semi-solids, and biologics, ensuring comprehensive coverage across different product types.

The checklist covers various aspects including study design, storage conditions, sampling plans, analytical methods, data analysis, and reporting of stability testing results.

By ensuring that stability testing procedures adhere to Good Manufacturing Practices (GMP) guidelines, this checklist helps maintain overall GMP compliance in pharmaceutical quality control and assurance.

This checklist is designed for use by stability program managers, quality control analysts, regulatory affairs specialists, and internal auditors in pharmaceutical companies, as well as external auditors and regulatory inspectors.

Stability testing audits should be conducted periodically, typically annually, or when significant changes occur in testing procedures, analytical methods, or regulatory requirements.

Benefits

Ensures compliance with ICH guidelines and pharmacopeia requirements for stability testing

Improves the accuracy and reliability of stability data

Helps in identifying and addressing potential stability issues early in product development

Supports informed decision-making on product shelf life and storage conditions

Facilitates regulatory submissions and approvals