Quality Control Samples

This article is to describe the process and requirements regarding Sample Management in Quality Control Laboratory , including the receipt, handling, controls, maintenance, distribution for testing, and destruction. The implementation of this procedure provides documented records of the chain of custody for the test samples to ensure their accountability and tractability.

This article (Laboratory Sample Management) is applicable for covers all samples received into the laboratory for routine analysis, including:  raw material sample, packaging material sample, in-process sample, finished product sample, and special study samples, such as water samples, environmental monitoring sample,   method verification / validation sample, method transfer samples, samples tested for regulatory submissions and samples received from external sources etc.

RESPONSIBILITY:

  • Sample submitter shall be responsible to:
    • Ensuring the sample submitted for testing was appropriately handled and is accurately labelled with identity, storage requirements, any special safety cautions, and the amount.
  • Sample coordinator or Lab In charge shall be responsible to:
    • Maintaining the sample records, including the logging of sample receipt, storage condition, distribution, and destruction.
    • Maintaining the sample in the designated and secure location, under appropriate storage conditions before distributing to analysts for testing.
    • Dispensing and/or distributing requisite amount of samples to the analysts based on the test requirements.
    • Informing the Head Quality Control (QC) or designee of any unusual observations or discrepancies identified with the samples.
  • Analyst shall be responsible for:
    • Maintaining the sample(s) being tested, in a secure location to ensure its integrity and be properly handled to prevent potential contamination.
    • Documenting the amounts used for testing.
    • Destruction of unused or left over quantity of samples.
  • Head Quality Control or Laboratory Manager shall be responsible for:
    • Ensuring that the sample management procedures are followed as written.
    • Ensuring a secure location for sample management with access and environmental controls.
    • Authorizing the destruction of unused or left over quantity of samples.
  • Quality Assurance Head or QA Manger shall be responsible for:
    • Ensuring proper implementation of this SOP at site.

Quality Control Sample Management -Sample receiving Procedure:

  • In this Laboratory Sample Management system, The Sample Coordinator (Sample Collector) having key role. He shall examine the test request form or other documents accompanying the delivered samples to ensure that the information on the reviewed documents accurately reflects the sample including the identification (e.g., Batch No., lot number, Product Code, Product number, bar coding, etc.), any pertinent safety cautions, physical condition of the sample, the amount delivered, and the prescribed storage condition.
  • Any discrepancies in the sample information, amount, etc., shall be addressed by the submitter. Samples requiring special handling or storage (e.g., temperature sensitive, hazardous, controlled substances, etc.) shall be addressed appropriately.
  • The Sample Coordinator does not have to perform a formal physical inspection of the samples upon receipt. However, if any unexpected or unusual observations are seen for the delivered samples, the coordinator shall notify the sample submitter and Head QC or designee.
  • The samples received are to be logged into the applicable logbooks and/or electronic database, or respective software which is designed for the same as per respective SOP for sample logging.
  • The following information associated with the received samples must be documented in the sample logbook or electronic database but not limited to:
    • Sample delivered by,
    • Delivery date of sample)
    • Quantity / amount of samples (received, used, and sent for destruction),
    • Name of sample,
    • Sample Batch Number /lot number/Identification number,
    • type of sample,
    • Sample received by,
    • Storage condition of the sample,
    • Storage location inside the laboratory,
    • Testing completion date,
    • Destruction date, and comments.

Laboratory Sample Management – Sample storage /maintenance:

Quality Control Samples

  • Upon receipt, while waiting for testing or transferring to another laboratory (e.g., contract testing facility) samples shall be placed in a designated secure storage location to prevent the unauthorized access in order to maintain the custody and integrity of the samples.
  • Samples shall be stored in an organized fashion to allow for easy retrieval and inventory.
  • Depending upon the required storage conditions, the received samples shall be stored at frozen, refrigerated, controlled, and/or ambient laboratory room conditions.
  • The environmental conditions (qualified and monitored) for the defined storage conditions shall be supported with proper temperature and humidity data to evidence that the samples were properly maintained prior to, during, and after testing until destruction. These requirements shall be followed for samples transferred to another laboratory for testing.

Also visit : Good Laboratory Practices 

Laboratory Sample Management -Sample custody transfers:

  • Samples may be transferred from the custody of the Sample Coordinator to the analyst(s) within the same laboratory or to an outside testing facility. The Sample Coordinator shall maintain records to evidence the custody transfer process and the traceability of the sample throughout its life cycle. Alternatively, this traceability may be addressed through computerized system.
  • There shall be no gap in the sample chain of custody.
  • Verification of the sample shall be performed by both the Sample Coordinator and the analyst(s) against documentation pertaining to the sample information submitted to ensure that the correct samples are being distributed for analysis.
  • Verification by both the Sample Coordinator and any outside laboratory receiving the samples shall be performed to ensure that the correct samples are being transferred. The verification of samples shall be performed by the outside laboratory against the sample information provided, e.g., Request for Analysis, Sample Request or any other associated paperwork accompanying the samples. Outside laboratory shall acknowledge the receipt of the samples based on the information provided by the sample coordinator

Laboratory Sample Management -Sample analysis:

  • Testing records shall include complete information regarding the samples being tested (e.g. sample name, batch/lot number, Unique  number generated by software like LIMS, amount, etc.).
  • A test sample, while under the custody of the analyst(s), shall be properly maintained in a secure location to ensure its integrity and be properly handled to prevent potential contamination. Once the analyst is done with the testing, they shall return the unused or left –over samples to the secure designated sample storage location where they are held until destroyed.
  • After all laboratory testing is complete and the sample testing is dispositioned, the Sample Coordinator shall update the sample log and arrange for proper sample destruction in coordination with the analyst (s)/ laboratory-in-charge for the destruction of that sample.

Quality Control Sample Management – Reconciliation:

  • Respective Department shall develop mechanisms and have written procedures in place for sample reconciliation in order to establish effective sample accountability and traceability that are critical with respect to data integrity.
  • Sample-reconciliation shall be performed to evidence that the amount of sample to be disposed is reconcilable with the received amount and the analyzed amount based on the records. If the actual amount of sample to be disposed of is not reconcilable based on the records, the Sample Coordinator shall inform the Head of QC to investigate the discrepancy (refer to the current version of the SOP for Deviation /Incidents and Investigations).
  • Samples shall be reconciled within reasonable tolerance limits that are specific to the sample type. The tolerances assigned should, however, be justified and capable of detecting any undocumented testing on the sample.

Quality Control Sample Management – Destruction:

  • The destruction of the test samples is authorized promptly after the sample testing is dispositioned.
  • Sample destruction is conducted in accordance with the laboratory waste management procedures and applicable site/region specific safety requirements and guidelines (e.g. DEA controlled guidelines in USA, NDPS Act in India).

Quality Control  Sample Management -Requirements:

  • Manufacturing Plant shall have written procedures in place for sample receipt and handling to ensure sample accountability and traceability.
  • Sampling and testing plans shall be described in written procedures. The procedure shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.
  • The laboratory shall have procedures for the transportation, receipt, handling, protection, storage retention and/or disposal of test items.  Including all provisions, but not limited to: data logger temperature readings, calibration certificates, storage unit records, etc., necessary to protect the integrity of the test item.

Laboratory Sample Management – Abbreviations used in the article:

  • DEA :  Drug Enforcement Agency
  • LIMS : Laboratory Information Management System
  • NDPS Act : Narcotic Drugs and Psychotropic Substances Act

Laboratory Sample Management – Definitions of terms used in the article:

  • Chain of Custody:
    • Refers to the ability to guarantee
      • the identity,
      • custody and
      • integrity of the sample from collection through reporting of the test results and sample disposal.
  • Sample Accountability:
    • Includes requirements for proof of sample receipt, proper storage, distributing for testing, analysis, and destruction authorization.
    • It is a record documenting that the sample’s integrity has been preserved and demonstrates continuity of handling.
  • Sample Coordinator :
    • Refers to the person(s) responsible for receiving samples into the laboratory,
    • Assuring the received samples are securely maintained under appropriate environmental conditions until the sample is transferred to the assigned analyst.
  • Sample Reconciliation:
    • Sample accountability is maintained throughout the life cycle of the samples
    • It is based on the sample records of amount sampled, received, used during testing and sent for destruction.
  • Test Sample Custody:
    • The test sample while in custody of the Sample coordinator and analysts must be fully documented
    • For recording the details use receiving log, usage log, destruction logs, etc.
    • The records must contain adequate and sufficient information.
    • The records are to  ensure the full accountability and traceability of samples throughout its life cycle.

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Yearly HPLC Calibration : Third Part

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