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STANDARD OPERATING PROCEDURE Page 2 of 9
Document Number: S-534 Version Beta
Handling of Laboratory Test Samples
Company Name:
Controls:
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: ________________________________
1. PURPOSE
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 .
3. GLOSSARY/DEFINITIONS
Item Explanation
4. REFERENCE DOCUMENTS
5. RESPONSIBILITIES
5.2. Analysts
5.4.3. Reviews and approves sample documents as part of the review of test
results.
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
When the sample reaches the receipt room the following should be done:
• Observes and records the condition of the sample and compares it with the
sample documentation as defined in Reference .
• 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 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.
7.1.4. The SHS formally accepts the sample, assigns a log number and logs it
into the sample database.
7.2.1. The SHS places samples awaiting analysis in the designated storage
area.
7.3.1. For each sample transfer the SHS and/or analyst documents the chain of
custody.
7.3.4. Excess portions of all samples are returned to the SHS for storage unless
justified and documented on the sample worksheet.
7.4.1. 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 should be included.
7.5.1. Samples are kept under lock and key while in the analyst’s possession.
7.6. Review of the Sample Documents, Sample Worksheets and Chain of Custody
7.6.2. QA reviews the sample documents, the sample worksheet and chain of
custody when reviewing the entire test protocol and test results.
7.7.2. The SHS documents the type, amount and storage conditions in the
sample database.
7.8.1. The SHS requests sample disposition, for example, when it is clear that
excess samples or reserve samples are no longer needed.
8. ATTACHMENTS
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: