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
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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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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