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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

Pharmaceuticals

Standard

ISO 17025

Workspaces

Pharmaceutical Laboratory

Occupations

Sample Management Specialist
Laboratory Technician
Quality Control Analyst
Stability Testing Coordinator
Laboratory Manager

Sample Management and Handling

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1
Is there a process in place to check sample integrity upon receipt?

Indicate if a sample integrity check process exists.

To ensure that samples have not been compromised before use.
2
Is there a documented chain of custody for each sample?

Select compliance status.

To ensure the integrity of the samples is maintained through proper documentation.
3
What is the required storage temperature for samples?

Enter the temperature in degrees Celsius.

To ensure samples are stored under conditions that maintain their integrity.
Min: -20
Target: 20
Max: 25
4
Describe the procedures for sample handling.

Provide detailed procedures for handling samples.

To assess the adequacy and clarity of the sample handling procedures.
5
Is there a proper identification system in place for each sample?

Select compliance status.

To ensure samples can be accurately identified and traced throughout the handling process.
6
Is there a process in place for reporting quality control incidents?

Indicate if an incident reporting process exists.

To ensure that any issues identified during quality control are properly reported and addressed.
7
When was the last quality control audit conducted?

Provide the date of the last audit.

To track the frequency of quality control audits and ensure compliance.
8
What is the minimum sample size required for quality testing?

Enter the minimum sample size.

To ensure sufficient sample size is available for accurate quality control testing.
Min: 1
Target: 10
Max: 100
9
What is the calibration schedule for quality control equipment?

Provide details of the calibration schedule.

To ensure that all equipment used in quality control is properly calibrated and maintained.
10
Are quality control procedures for samples documented and followed?

Select compliance status.

To ensure that proper quality control measures are in place to maintain sample integrity.
11
Have staff received training on sample traceability procedures?

Indicate if staff training on traceability has been conducted.

To ensure that all relevant personnel are knowledgeable about traceability practices.
12
When was the last review of the traceability documentation conducted?

Provide the date of the last review.

To ensure that the traceability documentation is regularly reviewed and updated.
13
What is the accuracy rate of the sample tracking system?

Enter the accuracy percentage.

To assess the reliability of the tracking system used for samples.
Min: 0
Target: 95
Max: 100
14
Describe the process for ensuring sample traceability.

Provide a detailed description of the traceability process.

To evaluate the effectiveness and clarity of the traceability process in place.
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15
Is there documentation in place to ensure traceability of each sample?

Select compliance status.

To verify that samples can be traced throughout their lifecycle from collection to analysis.
16
Is there an incident reporting mechanism for sample handling accidents?

Indicate if an incident reporting mechanism exists.

To ensure that any safety incidents are properly reported and addressed.
17
When was the last safety training conducted for sample handling?

Provide the date of the last safety training.

To ensure that personnel are regularly trained on safety protocols.
18
What percentage of emergency equipment is available in the sample handling area?

Enter the percentage of available emergency equipment.

To ensure that emergency equipment is readily accessible in case of incidents.
Min: 0
Target: 100
Max: 100
19
What safety procedures are in place for sample handling?

Provide a detailed description of the safety procedures.

To evaluate the adequacy of safety measures in place during sample handling.
20
Are personnel using appropriate personal protective equipment (PPE) when handling samples?

Select compliance status.

To ensure the safety of personnel and prevent contamination of samples.
21
Are there established procedures for the disposal of samples?

Indicate if disposal procedures are established.

To ensure that samples are disposed of in accordance with regulatory and safety requirements.
22
When was the last review conducted of sample lifecycle management procedures?

Provide the date of the last review.

To ensure that procedures are current and effective for proper sample management.
23
What is the average duration samples are stored before analysis?

Enter the average storage duration in days.

To ensure that samples are analyzed within a suitable timeframe to maintain integrity.
Min: 1
Target: 30
Max: 365
24
Describe the stages of the sample lifecycle from collection to disposal.

Provide a detailed description of the sample lifecycle stages.

To evaluate the clarity and thoroughness of the sample lifecycle management process.
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25
Is there comprehensive documentation for each stage of the sample lifecycle?

Select compliance status.

To ensure that all stages of sample management are documented for traceability and accountability.

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