Scribd Logo
Upload

Welcome to Scribd!

  • 208 views

    WI No. QC 003

    Uploaded by

    Khrystin Berdos
    This document outlines procedures for sampling incoming raw materials at a manufacturing plant. It specifies that sampling will be conducted by designated personnel from the Quality Control department on all incoming materials according to a sampling plan. Samples must be properly labeled and logged, with the container marked as sampled. Sampling equipment and practices are defined to ensure representative samples and avoid contamination.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    WI No. QC 003

    Uploaded by

    Khrystin Berdos
    208 views2 pages
    This document outlines procedures for sampling incoming raw materials at a manufacturing plant. It specifies that sampling will be conducted by designated personnel from the Quality Control department on all incoming materials according to a sampling plan. Samples must be properly labeled and logged, with the container marked as sampled. Sampling equipment and practices are defined to ensure representative samples and avoid contamination.

    Original Title

    WI no. QC 003.docx

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document outlines procedures for sampling incoming raw materials at a manufacturing plant. It specifies that sampling will be conducted by designated personnel from the Quality Control department on all incoming materials according to a sampling plan. Samples must be properly labeled and logged, with the container marked as sampled. Sampling equipment and practices are defined to ensure representative samples and avoid contamination.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    208 views2 pages

    WI No. QC 003

    Uploaded by

    Khrystin Berdos
    This document outlines procedures for sampling incoming raw materials at a manufacturing plant. It specifies that sampling will be conducted by designated personnel from the Quality Control department on all incoming materials according to a sampling plan. Samples must be properly labeled and logged, with the container marked as sampled. Sampling equipment and practices are defined to ensure representative samples and avoid contamination.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    WI No: QC 003 WORKING INSTRUCTION Revision no: 0

    TITLE: INCOMING RAW MATERIALS


    Date Issued: SAMPLING Effective Date:
    September 2019 Department December 2019
    QUALITY CONTROL
    Prepared by: Prepared by: Noted by:
    Khrystin J. Berdos Jhamaica L. Cabahug Engr. Darwin G.Tapia Page:
    R&D Assistant R&D Supervisor Plant Manager

    1.0 PURPOSE
    This working instruction outlines the incoming raw material sampling procedures.

    2.0 SCOPE
    This procedure applies to all incoming raw materials intended for production use.

    3.0 RESPONSIBILITY
    3.1 QC Receiver
    3.2 QC /QA sampler shall be clearly understand and strictly follow this SOP.

    4.0 PROCEDURE
    4.1 The Plant manager shall initiate the necessary sampling once the Good Received Note and
    the Certificate of Analysis (COA) from the principle are received and the raw material has
    been place under Quarantine area.
    4.2 Sampling will be carried out by the designated sampler and to be tested by the Quality control
    department.
    4.3 SAMPLING PLAN
    4.3.1 Active and main ingredients
    Each container will be sampled
    4.3.2 Excipients
    If not specified otherwise, the number of containers sampled is determined by the
    following formula. Number sample (X) equals to the square root of the quantity
    (N) plus 1 where N represents the number of units in each lot X is rounded to a
    whole number.
    4.4 Sampling shall be conducted according to the following manner:
     Clear the sampling area
     Wear gloves and mask
     Wipe up container before opening;
     Weigh accurately to the nearest tenth of gram and record;
     Clean up all the sampling tools before proceeds to different lot

    4.5 The collected samples must be properly labeled and the container which has been opened for
    sampling shall be marked “SAMPLED” to allow traceability. After sampling process, the
    sampling hole(s) should be closed with care to avoid cross contamination during storage.
    4.6 The number of samples taken and the container number being sampled must be recorded into
    the Sampling Logbook.
    4.7 Sampler will initial the Sampling Logbook and shall include:
     Raw material name;
     Supplier name;
     Inventory no;
     Container no sampled;
     Quantity of sample:
     Sampling procedure no;
     Number of samples taken;
     Signature of the sampler;
     Sampling date;
    4.8 Sampling guidance
    4.8.1 Sampling device
     Use stainless steel sampling devices especially designed for solid and
    liquid material.
     For liquid material received in small container use specially designed
    small stainless steel liquid sampler.
     For solid material received in bags use specially designed stainless solid
    sampler (Scoop).
     Clean and maintain the sampling device as per SOP on completion of
    sampling.

    4.8.2 Sampling guiidance


     Material to re-close the packages (such as sealing tape), as well as self-
    adhesive labels to indicate that a part of the contents has been remove
    from the package or container.
     Containers due to be sampled should be cleaned prior to sampling if
    necessary.
     The health and safety aspects should be taken care during sampling
    process.
     The container used to store a sample should not interact with the sampled
    material nor allow contamination. It should protect the sample from light,
    air, moisture, etc., as required by the storage directions for the material
    sampled.

    You might also like