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Pharmaceutical Stability Testing Program Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical stability testing programs, ensuring regulatory compliance, and maintaining the highest standards in stability data generation and management.

Pharmaceutical Stability Testing Program 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, providing evidence on how the quality of a drug substance or product varies over time under different environmental conditions. This Stability Testing Program Audit Checklist is designed to comprehensively evaluate the robustness and compliance of stability testing protocols in pharmaceutical organizations. By systematically assessing study design, sample management, testing conditions, data analysis, and documentation practices, this checklist helps ensure the reliability of stability data, supports regulatory compliance, and contributes to the overall quality and safety of pharmaceutical products throughout their shelf life.

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Industry

Pharmaceuticals

Standard

ICH Q1A(R2), ICH Q1B, ICH Q1C, FDA Guidance on Stability Testing

Workspaces

Pharmaceutical manufacturing plants

Occupations

Stability Program Managers
Quality Assurance Specialists
Analytical Chemists
Regulatory Affairs Managers
Formulation Scientists

Stability Testing Program Assessment

(0 / 4)

1
Please summarize the stability data analysis results.

Provide a detailed analysis of stability data.

To assess the interpretation and conclusions drawn from stability data.
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2
What is the duration of the stability study conducted?
To confirm that the study duration aligns with industry standards.
Min: 0
Target: 12
Max: 36
3
What method is used for shelf-life determination?

Provide the shelf-life determination method used.

To evaluate the adequacy of the method used for determining shelf-life.
4
Are the stability chambers compliant with ICH guidelines?

Select the compliance status of the stability chambers.

To ensure that stability testing is conducted under the correct environmental conditions.
5
Are the stability chambers calibrated regularly?

Indicate if regular calibration of stability chambers is performed.

To confirm that the stability chambers are maintained to ensure accurate testing conditions.
6
What is the frequency of temperature monitoring in the stability chambers?
To ensure that temperature monitoring is conducted at appropriate intervals.
Min: 0
Target: 24
Max: 48
7
When was the last stability test conducted?

Select the date of the last stability test.

To verify the currency of the stability testing data.
8
Is the stability testing protocol being adhered to?

Select the adherence status of the stability testing protocol.

To ensure that the established protocols for stability testing are being followed correctly.
9
Please summarize any equipment failure reports related to stability testing.

Provide details about any equipment failures and resolutions.

To assess the performance and reliability of stability testing equipment.
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10
What is the target humidity level for stability testing?
To ensure that the humidity levels are set according to stability testing requirements.
Min: 30
Target: 60
Max: 75
11
What is the reference number for the latest calibration certificate?

Provide the reference number for the latest calibration certificate.

To verify the calibration status of the equipment used.
12
Is the stability testing equipment properly maintained?

Select the maintenance status of the stability testing equipment.

To ensure that all equipment used for stability testing is in good working order.
13
Has the stability testing documentation been approved?

Indicate if the documentation has been approved.

To ensure that all documentation has received the necessary approvals.
14
What comments did the reviewer make regarding the documentation?

Provide any comments made by the reviewer during the documentation review.

To capture any feedback or required changes from the document reviewer.
15
When was the last review of stability testing documents conducted?

Select the date when the last document review was performed.

To confirm the currency of the documentation review process.
16
Is all necessary documentation for stability testing complete?

Select the completeness status of the stability testing documentation.

To ensure that all required documents are present for compliance and review.
17
Please describe the handling procedures for stability samples.

Provide detailed descriptions of the procedures for handling stability samples.

To ensure that proper procedures are followed to maintain sample integrity.
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18
What is the identification number for the stability samples?

Provide the identification number for the stability samples.

To ensure that each sample can be uniquely identified and tracked.
19
How many samples have been tested in the current batch?
To verify that the correct number of samples has been evaluated during stability testing.
Min: 1
Target: 20
Max: 100
20
Are the samples stored under the required stability conditions?

Select the status of sample storage conditions.

To ensure that samples are maintained in conditions that do not compromise their integrity.

FAQs

Key components include study design, sample selection and preparation, storage conditions, testing intervals, analytical methods, data analysis, and stability-indicating methods validation.

Comprehensive audits should be conducted annually, with more frequent assessments for critical products or when significant changes are made to the stability program.

The audit team should include stability experts, quality assurance personnel, analytical chemists, and regulatory affairs specialists familiar with current stability testing guidelines and regulations.

The checklist covers various stability study types, including long-term, accelerated, and stress testing, as well as considerations for different dosage forms and packaging configurations.

Yes, the checklist is designed to be applicable to stability testing programs for both drug substances and finished drug products, with specific sections addressing the unique requirements of each.

Benefits

Ensures compliance with ICH guidelines and regulatory requirements for stability testing

Enhances the reliability and consistency of stability data

Optimizes stability study designs and resource allocation

Improves shelf-life predictions and expiration date determinations

Supports global product registration and post-approval changes