A comprehensive checklist for ensuring ISO 17025 compliance in sample management and handling processes within pharmaceutical laboratories, focusing on sample integrity, traceability, and proper documentation throughout the testing lifecycle.
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About This Checklist
Proper sample management and handling are crucial aspects of ISO 17025 compliance in pharmaceutical laboratories. This specialized checklist focuses on ensuring that all stages of sample handling, from receipt to disposal, meet the stringent requirements set forth by ISO 17025 for the pharmaceutical industry. By addressing key areas such as sample identification, storage conditions, chain of custody, and integrity preservation, this checklist helps laboratory personnel maintain the quality and traceability of samples throughout the testing process. Implementing this checklist can significantly reduce the risk of sample mix-ups, contamination, or degradation, thereby enhancing the reliability of test results and supporting overall quality assurance in pharmaceutical analysis.
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Select compliance status.
Provide details of the calibration schedule.
Enter the minimum sample size.
Provide the date of the last audit.
Indicate if an incident reporting process exists.
Select compliance status.
Provide a detailed description of the traceability process.
Enter the accuracy percentage.
Provide the date of the last review.
Indicate if staff training on traceability has been conducted.
Select compliance status.
Provide a detailed description of the safety procedures.
Enter the percentage of available emergency equipment.
Provide the date of the last safety training.
Indicate if an incident reporting mechanism exists.
Select compliance status.
Provide a detailed description of the sample lifecycle stages.
Enter the average storage duration in days.
Provide the date of the last review.
Indicate if disposal procedures are established.
FAQs
Key elements include unique sample identifiers, date of receipt, source or origin of the sample, intended analysis, storage conditions, and any special handling requirements. The identification system should ensure unambiguous traceability throughout the sample's lifecycle in the laboratory.
Storage conditions should be continuously monitored using calibrated devices. Temperature, humidity, and light exposure (where applicable) should be recorded regularly. Any deviations from specified storage conditions must be documented and their impact on sample integrity assessed and reported.
ISO 17025 requires laboratories to have documented procedures for identifying, segregating, and handling non-conforming samples. This includes clear criteria for sample rejection, notification processes for clients, and procedures for documenting and investigating the non-conformity.
The checklist includes items to ensure compliance with sample retention policies, which should align with regulatory requirements and client agreements. It also covers proper documentation of sample disposal methods, dates, and authorizations to maintain a complete chain of custody record.
Yes, the checklist is designed to cover sample management practices for various types of testing in pharmaceutical laboratories. It includes general principles that apply to routine analytical samples as well as specific considerations for long-term stability testing samples, such as extended storage requirements and periodic condition checks.
Benefits
Ensures compliance with ISO 17025 sample management requirements specific to pharmaceutical testing
Reduces the risk of sample mix-ups, contamination, and degradation
Enhances traceability and chain of custody documentation
Supports data integrity by ensuring proper sample handling throughout the testing process
Improves overall efficiency and reliability of laboratory operations