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ISO 17025 Sample Management and Handling Checklist for Pharmaceutical Labs

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.

ISO 17025 Sample Management and Handling Checklist for Pharmaceutical Labs

by: audit-now
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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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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Pharmaceutical Facilities

Occupations

Sample Management Specialist
Laboratory Technician
Quality Control Analyst
Stability Testing Coordinator
Laboratory Manager
1
Is there a proper identification system in place for each sample?
2
Describe the procedures for sample handling.
3
What is the required storage temperature for samples?
Min: -20
Target: 20
Max: 25
4
Is there a documented chain of custody for each sample?
5
Is there a process in place to check sample integrity upon receipt?
6
Are quality control procedures for samples documented and followed?
7
What is the calibration schedule for quality control equipment?
8
What is the minimum sample size required for quality testing?
Min: 1
Target: 10
Max: 100
9
When was the last quality control audit conducted?
10
Is there a process in place for reporting quality control incidents?
11
Is there documentation in place to ensure traceability of each sample?
12
Describe the process for ensuring sample traceability.
13
What is the accuracy rate of the sample tracking system?
Min: 0
Target: 95
Max: 100
14
When was the last review of the traceability documentation conducted?
15
Have staff received training on sample traceability procedures?
16
Are personnel using appropriate personal protective equipment (PPE) when handling samples?
17
What safety procedures are in place for sample handling?
18
What percentage of emergency equipment is available in the sample handling area?
Min: 0
Target: 100
Max: 100
19
When was the last safety training conducted for sample handling?
20
Is there an incident reporting mechanism for sample handling accidents?
21
Is there comprehensive documentation for each stage of the sample lifecycle?
22
Describe the stages of the sample lifecycle from collection to disposal.
23
What is the average duration samples are stored before analysis?
Min: 1
Target: 30
Max: 365
24
When was the last review conducted of sample lifecycle management procedures?
25
Are there established procedures for the disposal of samples?

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 of ISO 17025 Sample Management and Handling Checklist for Pharmaceutical Labs

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