Single logo
LoginSign Up

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
4.5

Get Template

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.

Learn more

Industry

Healthcare

Standard

ICH Q1A - Stability Testing

Workspaces

Research Facilities

Occupations

Stability Scientist
Quality Control Analyst
Regulatory Affairs Specialist
Formulation Scientist
Quality Assurance Manager
1
Does the stability study design comply with ICH Q1A(R2) requirements?
2
What is the determined shelf-life of the product (in months)?
Min: 0
Target: 24
Max: 60
3
Was an appropriate method used for stability data analysis?
4
Please provide any notes related to regulatory compliance issues encountered.
5
Is the temperature control during stability testing within the specified range?
6
What is the monitored humidity level during the stability test (in %)?
Min: 20
Target: 50
Max: 80
7
What is the start date of the stability testing?
8
Are the sample handling procedures compliant with ICH guidelines?
9
Describe the adequacy of the study protocol used for stability testing.
10
Is the stability report available for review?
11
What is the date when the stability testing documentation was last reviewed?
12
How many deviations were recorded during the stability testing process?
Min: 0
Target: 0
Max: 100
13
Is the stability testing equipment calibrated and within its calibration date?
14
What is the accuracy of the temperature measurement in the testing equipment (in °C)?
Min: 0
Target: 0.5
Max: 2
15
Is there a maintenance log available for the stability testing equipment?
16
Please provide any notes related to equipment performance during stability testing.
17
What is the assessed risk level of the stability study?
18
What mitigation strategies are in place for identified risks?
19
How many risk factors have been identified for the stability study?
Min: 0
Target: 0
Max: 50
20
What is the date for the next risk review of the stability study?

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 of Pharmaceutical Stability Testing Program Audit Checklist

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