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									                   Standard Operating Procedure


              Reserve Samples in Laboratories




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 6
Document Number: S-535 Version 1.xx
Reserve Samples in Laboratories




Company Name:



Controls

Superseded document:      N/A, new

Reason for Revision       N/A

Effective Date:           February 1, 2012


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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Document Number: S-535 Version 1.xx
Reserve Samples in Laboratories




1. PURPOSE
    Reserve samples are important to verify original test results in case there is some
    doubt about those results. Sometimes reserve samples are also important for
    studies to get additional information. They are required by various regulations. This
    SOP addresses the process for taking, storing, transporting, and discarding reserve
    samples.



2. SCOPE

    The SOP applies to laboratories operating under FDA and equivalent international
    regulations. The SOP applies for raw material and finished products.



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).
      Split Samples     Two or more representative portions taken from a sample or
                        subsample and analyzed by different analysts or laboratories.
                        Split samples are used to replicate the measurement of the
                        variable(s) of interest. Also used as Reserve Samples.
      Subsample         A representative portion of a sample. See also aliquot
      Representative    Representative Sample means a sample that consists of a
      Sample            number of units that are drawn based on rational criteria such
      21CFR210.3        as random sampling and intended to assure that the sample
                        accurately portrays the material being sampled.
      Reserve           Samples used for retesting of the original sample if the initial
      Samples           test results is non-conforming (out of specifications). Reserve
                        samples should be taken from the same homogeneous material that
                        was originally collected from the lot, tested, and yielded the OOS
                        results. Sometimes also called Retention Samples as required by the


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STANDARD OPERATING PROCEDURE                                                   Page 4 of 6
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Reserve Samples in Laboratories

                        FDA to be retained for the FDA in case the agency wants to analyze
                        the sample.

    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

    4.2. SOP S-535: “Handling of Laboratory Test Samples”
        Order from www.labcompliance.com/solutions/sops



5. RESPONSIBILITIES

   5.1. Sampling Engineer

        5.1.1. Gets trained and follows this SOP and the sampling plan.

        5.1.2. Takes reserve samples according to the sampling plan

        5.1.3. Documents sampling and any deviation from the sampling plan in
               sampling protocols.

   5.2. Sampling Engineer’s Supervisor

        5.2.1. Ensures proper training of the Sampling Engineers.

        5.2.2. Reviews sampling protocols.

   5.3. Quality Assurance Department

        5.3.1. Advises on regulations and guidelines related to sampling.

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




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        5.3.3. Reviews and approves sampling plans and sampling protocols as part of
               review of test results.



6. FREQUENCY OF USE

   6.1. Whenever reserve samples are taken, stored and discarded.



7. PROCEDURE

   7.1. For each batch of material that is tested in the laboratory a representative
        reserve sample should be taken

   7.2. The reserve sample should be identical to the original sample.

   7.3. The reserve sample should be stored in the same immediate container-closure
        system in which the marketed drug product is stored or in one that has
        essentially the same characteristics

   7.4. The quantity of reserve samples should be 2.5 times that needed to perform al
        required testing on the sample.

   7.5. Reserve samples should be taken following the SOP in reference 4.1

   7.6. Reserve samples should be handled and discard in accordance with the SOP in
        reference 4.2

   7.7. Reserve samples should be processed and analyzed in the same was as the
        original sample. This also includes sample preparation and data handling.

   7.8. If the original sample requires milling or homogenization the reserve samples
        should be taken after these steps.

   7.9. Reserve samples should be retained for at least one year beyond the expiration
        date of the product batch that it represents

   7.10. For raw material the retention time is at least one year beyond the expiration
        date of the product for which the raw material was use




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STANDARD OPERATING PROCEDURE                                                   Page 6 of 6
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   7.11. During storage the reserve sample should be visually inspected at least once a
        year for evidence of deterioration unless visual examination would affect the
        integrity of the reserve sample

   7.12. Any evidence of reserve sample deterioration should be investigated

   7.13. The results of the examination should be recorded and maintained with other
        stability data on the drug product




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