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    02.SOP of Retention Sample (Raw Material)

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    Bejoy Karim
    This standard operating procedure outlines the process for withdrawing, storing, observing, and destroying control/retention samples from pharmaceutical production and finished products at Gentry Pharmaceuticals Ltd. The procedure specifies that samples will be withdrawn from each batch and stored at no more than 25°C. Samples will be physically observed every six months and records will be maintained. Control samples will be destroyed one year after expiry date. The document provides responsibilities, sample quantities, storage requirements, and record keeping for ensuring proper control sample management.

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    02.SOP of Retention Sample (Raw Material)

    Uploaded by

    Bejoy Karim
    3K views5 pages
    This standard operating procedure outlines the process for withdrawing, storing, observing, and destroying control/retention samples from pharmaceutical production and finished products at Gentry Pharmaceuticals Ltd. The procedure specifies that samples will be withdrawn from each batch and stored at no more than 25°C. Samples will be physically observed every six months and records will be maintained. Control samples will be destroyed one year after expiry date. The document provides responsibilities, sample quantities, storage requirements, and record keeping for ensuring proper control sample management.

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    This standard operating procedure outlines the process for withdrawing, storing, observing, and destroying control/retention samples from pharmaceutical production and finished products at Gentry Pharmaceuticals Ltd. The procedure specifies that samples will be withdrawn from each batch and stored at no more than 25°C. Samples will be physically observed every six months and records will be maintained. Control samples will be destroyed one year after expiry date. The document provides responsibilities, sample quantities, storage requirements, and record keeping for ensuring proper control sample management.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    3K views5 pages

    02.SOP of Retention Sample (Raw Material)

    Uploaded by

    Bejoy Karim
    This standard operating procedure outlines the process for withdrawing, storing, observing, and destroying control/retention samples from pharmaceutical production and finished products at Gentry Pharmaceuticals Ltd. The procedure specifies that samples will be withdrawn from each batch and stored at no more than 25°C. Samples will be physically observed every six months and records will be maintained. Control samples will be destroyed one year after expiry date. The document provides responsibilities, sample quantities, storage requirements, and record keeping for ensuring proper control sample management.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
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    The key takeaways are the procedures for withdrawing, storing, observing, and destroying control samples from production and finished pharmaceutical products.

    The purpose of this SOP is to lay down the procedure for withdrawing, storing, observing, and destroying control samples from production and finished pharmaceutical products like oral boluses, solutions, powders, etc.

    The responsibilities outlined in this SOP are that the QA officer is responsible for collecting finished product control samples and the QC personnel are responsible for collecting raw material retention samples. The QA head is accountable for implementing this SOP.

    GENTRY PHARMACEUTICALS LTD.

    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Document Title SOP on withdrawal, Storage, Observation & Destruction of Control/Retention Sample

    SOP No.: SOP/QC/002 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. Abbreviations and Definitions
    6. Procedure of Withdrawal for Control Sample
    7. Storage of control sample
    8. Physical observation of control sample
    9. Destruction of Control Sample
    10. Distribution List
    11. Revision History

    1.0 Objective

    To lay down the procedure to withdrawal, storage, observation & destruction of control sample from
    production Oral Bolus, Solution & Powder, QC (RM Retention) and finished product.

    2.0 Scope

    This Standard Operating Procedure is applicable for withdrawal, storage, observation & destruction of
    control sample from production Oral Bolus, Solution & Powder, QC (RM Retention) and finished product in
    Gentry pharmaceuticals Ltd.

    3.0 Responsibility

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 1 of 5
    GENTRY PHARMACEUTICALS LTD.
    Vangnahati, Sreepur, Gazipur.

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Name of Material SOP on withdrawal, Storage, Observation & Destruction of Control/Retention Sample

    SOP No.: SOP/QC/002 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

    QA/QC officer or above is responsible for withdrawal, storage, observation & destruction of control sample.

    4.0 Accountability

    QA/QC Head shall be accountable for implementation of this SOP.

    5.0 Abbreviations and Definitions

    SOP                             :            Standard Operating Procedure

    QA                              :            Quality Assurance

    6.0 Procedure of Withdrawal for Control Sample

    Control sample shall be withdrawn from each batch of product manufactured.

    Quantity of sample shall be withdrawn as per Table-I

    Sl. No. Sample Quantity of Sample withdrawn (in Pack Size)

    01. Bolus Any Pack Size 1 Box

    02. Powder 100 & 500 gm Pack Size 2 Pcs & 1 Kg Pack Size 1 Pc

    03. Solution 100 & 500 ml Pack Size 2 Pcs & 1 Liter 1 Pc

    04. Suspension 100 & 500 ml Pack Size 2 Pcs & 1 Liter 1 Pc

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 2 of 5


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

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Name of Material SOP on withdrawal, Storage, Observation & Destruction of Control/Retention Sample

    SOP No.: SOP/QC/002 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

    The QA Officer shall collect the finished product control sample from each batch throughout packing
    operation as per quantity mentioned in the table-I and make the entry in finished product control sample
    logbook as per Annexure No.-I

    For Raw Material retention sample, the QC personnel shall collect the sample and make the entry in raw
    material retention sample logbook as per Annexure No.-II

    Control Sample sticker label shall be stick on each pack as per Annexure No.-III

    The control sample shall be proportionately representing from all different pack size in same batch sales/
    Physician sample’

    Liquid and solvent are not retained in control sample room.

    7.0 Storage of Control Sample

    The control sample shall be stored at temperature NMT 25° C.

    The record of temperature monitoring of control sample room shall be maintained as per “SOP on
    monitoring of temperature and relative humidity”.

    8.0 Physical Observation of Control Sample

    Physical observation will be carried out after every six month and the observation records will be maintained
    as per the Annexure No.-V

    During physical observation following points shall be considered where ever applicable but not limited to:

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 3 of 5


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

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Name of Material SOP on withdrawal, Storage, Observation & Destruction of Control/Retention Sample

    SOP No.: SOP/QC/002 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

    Appearance/Description, Packing Quality, Imprinting, Overprinting, Intactness of package, delamination,


    Peeling/Motting of Bolus.

    In case, quantity of control sample / retention sample is required for testing/reference purpose, the same
    shall be issued only after the approval of the request as per the Annexure No.-IV, such withdrawal shall be
    recorded in ‘Finished product control sample logbook’& ‘Raw material retention sample logbook ‘as per
    Annexure No.-I & Annexure No.-II respectively.

    9.0 Destruction of Control Sample

    Control sample & Retention sample shall be destroyed after one year of expiry date. For destruction of
    control sample refer ‘SOP on destruction of drugs products and its components’.

    Destruction record of finished product control sample & raw material retention sample will be maintained in
    ‘Finished product control sample logbook’ as per the Annexure No.-I & ‘Raw material retention sample
    logbook ‘as per Annexure No.-II

    10.0 DISTRIBUTION LIST

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

    Quality Assurance Master & Control Copy 02

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 4 of 5


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

    QUALITY ASSURANCE DEPARTMENT


    STANDARD OPERATING PROCEDURE
    Name of Material SOP on withdrawal, Storage, Observation & Destruction of Control/Retention Sample

    SOP No.: SOP/QC/002 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

    Quality Control Control Copy 01

    11.0 Revision History

    SOP No Version No Date Reason of Revision

    To set the details guideline and new initiated for withdrawal,


    SOP/QC/002 01 01.01.2019 Storage, Observation & Destruction of Control/Retention
    Sample

    WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 5 of 5


    DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED

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