1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples.
2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples.
3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOP
The Assistant Manager QC and/or QA Manager are responsible for Overall compliance with this SOP.
4.0 PROCEDURE for Handling of Laboratory Samples:
4.1 After sampling is completed, samples must be promptly transported to the laboratory for analysis.
4.2 Raw materials samples should always be accompanied by a completed sampling report.
4.3 Intermediate product samples must be accompanied by a report detailing physical tests.
4.4 In the samples register, record:
- Product name
- Quantity
- Batch number
- Date received
- Name of the person delivering the sample
- Name of the person receiving the sample
4.5 Hand over all samples to the responsible person or their designate. Ensure samples are duly recorded in the samples register and assigned to an analyst.
Related SOP: SOP for Retesting and Resampling of Raw materials
4.6 Allocate a unique control number to each sample in the provided registers.
4.7 Store samples securely in the lock and key cabinet or in a dedicated area, preventing tampering. Samples requiring specific storage conditions should be stored accordingly.
4.8 Samples must be analyzed within a maximum of two weeks from receipt unless a valid justification should be there for an extended duration.
4.9 Provide the designated QC analyst with a sample sufficient for one chemical/microbiology test. Store the remaining portion in the analyzed samples storage area.
Related SOP: Handling of Laboratory Incidents in Pharma
5.0 ABBREVIATIONS:
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6.0 ANNEXURE:
Nil
7.0 REVISION HISTORY:
Nil
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