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GLP Test Article Handling and Storage Audit Checklist

A comprehensive checklist for auditing the handling, storage, and management of test articles in GLP-regulated pharmaceutical research, ensuring compliance and maintaining the integrity of research materials.

GLP Test Article Handling and Storage Audit Checklist

by: audit-now
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About This Checklist

Proper handling and storage of test articles is critical for maintaining the integrity of pharmaceutical research conducted under Good Laboratory Practice (GLP) standards. This GLP Test Article Handling and Storage Audit Checklist is designed to help quality assurance personnel, study directors, and laboratory managers evaluate and improve processes related to the receipt, storage, handling, and disposal of test articles. By implementing this checklist, pharmaceutical organizations can ensure compliance with GLP regulations, maintain the quality and stability of test articles, and enhance the overall reliability of their research studies.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research Facilities

Occupations

Quality Assurance Specialist
Study Director
Laboratory Manager
Test Article Coordinator
GLP Compliance Officer
1
Is there a documented procedure for the traceability of test articles?
2
Are integrity checks performed on samples before testing?
3
What is the current storage temperature for test articles?
Min: 15
Target: 20
Max: 25
4
Are all test articles stored in compliance with GLP regulations?
5
Are there established handling protocols for all test substances?
6
What is the procedure for reporting incidents involving test substances?
7
Provide details on training records for personnel handling test substances.
8
When was the last review of the handling procedures conducted?
9
Are there documented quality control procedures for test articles?
10
What is the sample size used for quality control testing?
Min: 5
Target: 10
Max: 50
11
Is quality control testing conducted on a regular basis?
12
Document any findings or deviations from the quality control procedures.
13
Is there an inventory tracking system in place for test articles?
14
What is the maximum inventory level for test articles?
Min: 50
Target: 100
Max: 200
15
Are regular audits conducted on the test article inventory?
16
What is the procedure for handling inventory discrepancies?
17
Are there documented disposal protocols for test articles?
18
When was the last review of disposal procedures conducted?
19
Have personnel received training on disposal procedures for test articles?
20
Document any incidents related to the disposal of test articles.

FAQs

The checklist covers areas such as receipt and logging procedures, storage conditions, labeling and identification, handling and dispensing practices, expiration date monitoring, and disposal protocols for test articles.

Audits should be conducted at least semi-annually, with more frequent checks recommended for high-turnover test articles or when there are significant changes in storage facilities or handling procedures.

The audit should be conducted by quality assurance personnel in collaboration with study directors and laboratory managers responsible for test article management.

By ensuring proper handling and storage of test articles, this checklist helps maintain the quality and stability of materials used in studies, thereby supporting the validity and reproducibility of research results.

Yes, while maintaining core GLP principles, the checklist can be tailored to address specific requirements for different types of test articles, such as small molecules, biologics, or medical devices.

Benefits of GLP Test Article Handling and Storage Audit Checklist

Ensures compliance with GLP regulations for test article management

Minimizes risks of test article contamination, degradation, or mix-ups

Improves traceability and documentation of test article lifecycle

Enhances the reliability and reproducibility of research studies

Facilitates efficient inventory management of test articles