Standard Operating Procedure

Handling of Laboratory Test Samples

This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

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STANDARD OPERATING PROCEDURE Page 2 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

Company Name:

Controls:

Superseded Document N/A, new

Reason for Revision N/A

Effective Date March 1, 2008

Signatures:

Author I indicate that I have authored or updated this SOP according to applicable business requirements and our company procedure: Preparing and Updating Standard Operating Procedures.

Name: ________________________________

Signature: ________________________________

Date: ________________________________

Approver I indicate that I have reviewed this SOP, and find it meets all applicable business requirements and that it reflects the procedure described. I approve it for use.

Name: ________________________________

Signature: ________________________________

Date: ________________________________

Reviewer I indicate that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. I approve it for use.

Name: ________________________________

Signature: ________________________________

Date: ________________________________

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STANDARD OPERATING PROCEDURE Page 3 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

1. PURPOSE

Thorough handling of samples is important to ensure integrity of samples, to prevent deterioration and cross contamination, to maintain sample tracking and the chain of custody and to ensure safe disposal. This is important to ensure accurate test results. This SOP addresses the process for handling sampling and testing.

2. SCOPE

The SOP applies to laboratories operating under FDA and equivalent international regulations and to laboratories operating under ISO 17025 and equivalent quality systems. Sample handling covers the steps from the time the sample is received in the laboratory until it is disposed of. This includes sample transport and sample storage, sample tracking and sample custody. The SOP is limited to transport and storage that is under control of the laboratory. The SOP does not apply to sampling procedures. For sampling procedures refer to Reference 4.1.

3. GLOSSARY/DEFINITIONS

Item Explanation

Sample Representative quantity of material extracted from a batch of reference material.

Aliquot Aliquot — An aliquot is a portion of a sample that is representative of the entire sample (see also subsample).

Chain of Custody

An unbroken trail of accountability that insures the physical security of samples, data and records.

Sample Tracking

A system of following a sample from receipt at the laboratory, through sample processing and analysis to final reporting. The system includes unique numbering or bar coding labels and the use of a sample log.

SHS (Authorized) Sample Handling Specialist

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STANDARD OPERATING PROCEDURE Page 4 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

Log Number The number used as a unique identifier of a sample, usually assigned by the laboratory. 

Note: For other definitions, see www.labcompliance.com/glossary.

4. REFERENCE DOCUMENTS

4.1. SOP S-531: “Sampling for Analytical Testing”.Order from www.labcompliance.com/solutions/sops.

5. RESPONSIBILITIES

5.1. Sample Handling Specialist (SHS)

5.1.1. Receives and documents samples.

5.1.2. Documents chain of custody when transferring samples.

5.1.3. Documents any observations related to the sample.

5.2. Analysts

5.2.1. Document chain of custody when transferring samples.

5.3. Laboratory Supervisor

5.3.1. Ensures proper training of the SHS and analysts.

5.3.2. Reviews sample documents and chain of custody.

5.3.3. Authorizes sample disposal.

5.4. Quality Assurance Department

5.4.1. Advises on regulations and guidelines related to sample handling.

5.4.2. Checks if processes and documentation are in compliance with internal policies and regulations/guidelines.

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STANDARD OPERATING PROCEDURE Page 5 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

5.4.3. Reviews and approves sample documents as part of the review of test results.

6. FREQUENCY OF USE

6.1. Whenever test samples are received, stored, transferred and disposed of.

6.2. Whenever reserve or reference samples are received, stored, transferred and disposed of.

7. PROCEDURE

7.1. Sample Receipt

When the sample reaches the receipt room the following should be done:

7.1.1. The SHS who is authorized to receive the sample;

Verifies that the sample is accompanied by appropriate sample documentation.

Verifies that the sample package is consistent with the documentation.

Observes and records the condition of the sample and compares it with the sample documentation as defined in Reference 4.1.

Checks the sample package for proper sealing and physical damage.

7.1.2. If the documentation is incomplete or inconsistent with the sample package or if there is any other problem;

The SHS informs the supervisor.

The sample is held until the discrepancy is clarified.

The SHS arranges for transport to the storage room if timely clarification cannot be satisfactorily obtained.

7.1.3. In the case of no clarification the sample is rejected and sent back to the requestor.

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7.1.4. The SHS formally accepts the sample, assigns a log number and logs it into the sample database.

As a minimum information as shown in Attachment 8.1 should be entered.

7.2. Sample Storage

7.2.1. The SHS places samples awaiting analysis in the designated storage area.

7.2.2. Samples should be stored frozen, refrigerated or at room temperature. Controlled drug substances are stored in a separate locked area.

7.2.3. The sample storage areas should be organized to prevent contamination or cross contamination.

7.2.4. Temperatures in all controlled areas should be monitored and an alarm should be triggered if the temperature exceeds specified temperature limits.

7.3. Sample Transfer within the Laboratory

7.3.1. For each sample transfer the SHS and/or analyst documents the chain of custody.

7.3.2. Samples received by the analysts are documented on the sample worksheet.

7.3.3. Samples transferred between analysts are documented on the sample worksheet.

7.3.4. Excess portions of all samples are returned to the SHS for storage unless justified and documented on the sample worksheet.

7.4. Sample Transfer Outside the Laboratory

7.4.1. The SHS enters any sample transfer outside the laboratory in the sample database and the sample worksheet. As a minimum information as shown in Attachment 8.2 should be included.

7.4.2. Samples are shipped according to work instructions as documented in Attachment 8.2.

7.5. Sample Storage During Analysis

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STANDARD OPERATING PROCEDURE Page 7 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

7.5.1. Samples are kept under lock and key while in the analyst’s possession.

7.5.2. If lockable storage is not obtainable or practical, or does not ensure sample integrity, the sample is returned to the designated storage area.

7.6. Review of the Sample Documents, Sample Worksheets and Chain of Custody

7.6.1. The lab supervisor reviews the sample documents, the sample worksheet and chain of custody when reviewing the entire test protocol and test results.

7.6.2. QA reviews the sample documents, the sample worksheet and chain of custody when reviewing the entire test protocol and test results.

7.7. Reserve Samples

7.7.1. Reserve samples are stored in the designated storage area.

7.7.2. The SHS documents the type, amount and storage conditions in the sample database.

7.8. Sample Disposition

7.8.1. The SHS requests sample disposition, for example, when it is clear that excess samples or reserve samples are no longer needed.

7.8.2. The disposal is approved by the laboratory supervisor.

7.8.3. The sample is disposed of in accordance with federal regulations and laboratory procedures.

7.8.4. The SHS documents the disposal in the sample database.

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STANDARD OPERATING PROCEDURE Page 8 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

8. ATTACHMENTS

8.1. Attachment – Documenting Sample Receipt

Sample log number:

Sample received from:

Date/Time of receipt:

Received by:

Sample description:

Number of packages:

Total sample amount:

Description/content of package 1:

Description/content of package 2:

Conditions of samples and packages:

Storage location:

Storage conditions:

Required test

Priority of testing (deadline):

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STANDARD OPERATING PROCEDURE Page 9 of 9Document Number: S-534 Version Beta Handling of Laboratory Test Samples

8.2. Attachment – Documenting Sample Transfer Outside the Laboratory

Sample description:

Number of packages:

Total sample amount:

Description/content of package 1:

Description/content of package 2:

Preparation for delivery by:

Type of sealing:

Delivery address (person, organization, department):

Work instructions to ensure sample integrity:

Date of shipment:

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