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    01.collection, Storage and Control of Reserve Samples For Drug Products

    Uploaded by

    Bejoy Karim
    This standard operating procedure outlines the collection, storage, and control of reserve samples for drug products at Gentry Pharmaceuticals Ltd. It defines responsibilities for quality assurance officers to collect, store, retrieve, and dispose of reserve samples according to procedures. Samples must be retained for at least one year past the expiration date or three years after distribution if no expiration date. Reserve samples are examined annually and any deterioration is documented and investigated.

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

    01.collection, Storage and Control of Reserve Samples For Drug Products

    Uploaded by

    Bejoy Karim
    459 views4 pages
    This standard operating procedure outlines the collection, storage, and control of reserve samples for drug products at Gentry Pharmaceuticals Ltd. It defines responsibilities for quality assurance officers to collect, store, retrieve, and dispose of reserve samples according to procedures. Samples must be retained for at least one year past the expiration date or three years after distribution if no expiration date. Reserve samples are examined annually and any deterioration is documented and investigated.

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    01.Collection, Storage and Control of Reserve Samples for Drug Products

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    This standard operating procedure outlines the collection, storage, and control of reserve samples for drug products at Gentry Pharmaceuticals Ltd. It defines responsibilities for quality assurance officers to collect, store, retrieve, and dispose of reserve samples according to procedures. Samples must be retained for at least one year past the expiration date or three years after distribution if no expiration date. Reserve samples are examined annually and any deterioration is documented and investigated.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    459 views4 pages

    01.collection, Storage and Control of Reserve Samples For Drug Products

    Uploaded by

    Bejoy Karim
    This standard operating procedure outlines the collection, storage, and control of reserve samples for drug products at Gentry Pharmaceuticals Ltd. It defines responsibilities for quality assurance officers to collect, store, retrieve, and dispose of reserve samples according to procedures. Samples must be retained for at least one year past the expiration date or three years after distribution if no expiration date. Reserve samples are examined annually and any deterioration is documented and investigated.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 4

    GENTRY PHARMACEUTICALS LTD.

    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Document Title Collection, Storage and Control of Reserve Samples for Drug Products

    SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

    Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

    Prepared by Checked by Approved by

    Sign. & Date

    Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

    Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

    CONTENT
    1. Objective
    2. Scope
    3. Responsibility
    4. Accountability
    5. Procedure
    6. Distribution List
    7. Revision History

    1.0 OBJECTIVE:

    To lay down a procedure for collection, storage, retrieval and disposition of reserve samples of drug
    products.

    2.0 SCOPE

    This SOP shall be applicable to concern department in Gentry Pharmaceuticals Ltd.

    3.0 RESPONSIBILITY:

    Quality Assurance Officer for collection, storage, retrieval and disposal of reserve samples.
    Head of Quality Assurance Department to ensure compliance.

    4.0 ACCOUNTABILITY

    Quality Assurance Manager

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 1 of 4
    GENTRY PHARMACEUTICALS LTD.
    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Document Title Collection, Storage and Control of Reserve Samples for Drug Products

    SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

    Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

    Prepared by Checked by Approved by

    Sign. & Date

    Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

    Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

    5.0 PROCEDURE:

    Every batch/lot of each drug product in all forms of its packing shall be sampled for reserve sample
    separately.

    During the primary packing of drug product the concerned QA Officer shall collect reserve samples that are
    representative of batch of drug product. The reserve sample shall be collected at equal intervals throughout
    primary
    packing operation of the batch.

    The quantity of reserve samples should be at least twice the quantity necessary to perform all the required
    tests.

    The reserve samples shall be stored in the same immediate container-closure system in which the drug
    product is to be marketed.

    The reserve samples shall be stored under conditions consistent with the product labeling.

    If the drug products are bulk packed, then the reserve samples shall be kept in the same type of packing
    like that of bulk packing but in small scale.

    The Officer-QA shall enter the details in “Reserve sample register” for drug products.

    For all drug products, the reserve samples shall be retained for not less than one year after the expiration
    date of the drug product.

    For drug product that is exempted from bearing an expiration date, the reserve sample must be retained for
    not less than 3 years after the batch of the drug product is distributed.

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 2 of 4
    GENTRY PHARMACEUTICALS LTD.
    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Document Title Collection, Storage and Control of Reserve Samples for Drug Products

    SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

    Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

    Prepared by Checked by Approved by

    Sign. & Date

    Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

    Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

    Reserve samples shall be examined visually at least once a year for all commercial batches for evidence of
    deterioration, unless visual examination would affect the integrity of the reserve samples (containers).

    The results of periodic examination of reserve samples shall be recorded with other stability data of drug
    product.

    Any evidence of reserve sample deterioration shall be investigated and documented.

    At least one packed unit from each lot is to remain unopened in the event chemical testing has to be
    performed.

    In case of retrieval of any reserve sample the concerned personnel shall fill the “Reserve sample issue
    request” and get the approval from Head of Quality Assurance Department Officer-QA shall issue the drug
    product requested and fill the request

    After the completion of retention period, the concerned Officer-QA shall destroy the sample by incinerating
    and enter the disposed o􀃗 date and signature in the reserve sample register for drug products.

    6.0. DISTRIBUTION LIST

    Department Master/Control Copy No. of Copy Received By (Signature & Date)

    Quality Assurance Master & Control Copy 02

    Quality Control Control Copy 01

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 3 of 4
    GENTRY PHARMACEUTICALS LTD.
    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Document Title Collection, Storage and Control of Reserve Samples for Drug Products

    SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

    Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

    Prepared by Checked by Approved by

    Sign. & Date

    Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

    Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

    7.0 Revision History

    SOP No Version No Date Reason of Revision

    To set the details proper guideline and new initiated for


    SOP/QC/001 01 01.01.2019 Collection, Storage and Control of Reserve Samples for
    Drug Products.

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 4 of 4

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