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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

Healthcare

Standard

Pharmaceutical Stability Testing Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Stability Program Managers
Quality Assurance Specialists
Analytical Chemists
Regulatory Affairs Managers
Formulation Scientists
1
Are the stability chambers compliant with ICH guidelines?
2
What method is used for shelf-life determination?
3
What is the duration of the stability study conducted?
Min: 0
Target: 12
Max: 36
4
Please summarize the stability data analysis results.
5
Is the stability testing protocol being adhered to?
6
When was the last stability test conducted?
7
What is the frequency of temperature monitoring in the stability chambers?
Min: 0
Target: 24
Max: 48
8
Are the stability chambers calibrated regularly?
9
Is the stability testing equipment properly maintained?
10
What is the reference number for the latest calibration certificate?
11
What is the target humidity level for stability testing?
Min: 30
Target: 60
Max: 75
12
Please summarize any equipment failure reports related to stability testing.
13
Is all necessary documentation for stability testing complete?
14
When was the last review of stability testing documents conducted?
15
What comments did the reviewer make regarding the documentation?
16
Has the stability testing documentation been approved?
17
Are the samples stored under the required stability conditions?
18
How many samples have been tested in the current batch?
Min: 1
Target: 20
Max: 100
19
What is the identification number for the stability samples?
20
Please describe the handling procedures for stability samples.

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 of Pharmaceutical Stability Testing Program Audit Checklist

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