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    6 - Leofran Oral Solution

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    ShagorShagor
    1. The document is an in-process analysis request and report sheet from the production department to the quality assurance department of Leon Pharmaceuticals for a batch of Leofran Oral Solution. 2. It requests analysis at three stages: after mixing, at the beginning of filling, and after final packing. The analyses include checks for appearance, identification, odor, taste, pH, weight per ml, assay, filled volume, cap leakage, batch number, and manufacturing and expiration dates. 3. The production department requests analysis and reports the results to quality assurance, who signs off to release the batch at each stage of production.

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    © All Rights Reserved
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    6 - Leofran Oral Solution

    Uploaded by

    ShagorShagor
    32 views2 pages
    1. The document is an in-process analysis request and report sheet from the production department to the quality assurance department of Leon Pharmaceuticals for a batch of Leofran Oral Solution. 2. It requests analysis at three stages: after mixing, at the beginning of filling, and after final packing. The analyses include checks for appearance, identification, odor, taste, pH, weight per ml, assay, filled volume, cap leakage, batch number, and manufacturing and expiration dates. 3. The production department requests analysis and reports the results to quality assurance, who signs off to release the batch at each stage of production.

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    DOUI

    Original Title

    6- Leofran Oral Solution

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    1. The document is an in-process analysis request and report sheet from the production department to the quality assurance department of Leon Pharmaceuticals for a batch of Leofran Oral Solution. 2. It requests analysis at three stages: after mixing, at the beginning of filling, and after final packing. The analyses include checks for appearance, identification, odor, taste, pH, weight per ml, assay, filled volume, cap leakage, batch number, and manufacturing and expiration dates. 3. The production department requests analysis and reports the results to quality assurance, who signs off to release the batch at each stage of production.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    32 views2 pages

    6 - Leofran Oral Solution

    Uploaded by

    ShagorShagor
    1. The document is an in-process analysis request and report sheet from the production department to the quality assurance department of Leon Pharmaceuticals for a batch of Leofran Oral Solution. 2. It requests analysis at three stages: after mixing, at the beginning of filling, and after final packing. The analyses include checks for appearance, identification, odor, taste, pH, weight per ml, assay, filled volume, cap leakage, batch number, and manufacturing and expiration dates. 3. The production department requests analysis and reports the results to quality assurance, who signs off to release the batch at each stage of production.

    Copyright:

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

    LEON PHARMACEUTICALS LIMITED

    Satkhamair, Sreepur, Gazipur.


    Department Quality Assurance
    Title In-Process Analysis Request & Report Sheet
    SYRUP MO No.:

    From: Production Department To: QA Department


    Product Name : Leofran Oral Solution Batch No.:
    Product Code : LFSY06 Batch Size:
    Product Strength : Ondansetron 4.0 mg / 5ml QC Ref No.:

    Sl. Quality Control Department


    No. Production Department

    01. ANALYSIS REQUEST SPECIFICATIONS ANALYSIS REPORT


    Interim report after mixing thoroughly:
    1. Appearance 1. A banana flavoured liquid having sweet taste free from 1.
    any visible foreign particles.

    2. Identification 2. Must comply with the identification test for 2.


    Ondansetron HCL Dihydrate .
    3. Odour 3.
    3. A blended flavour of banana .
    4. Taste 4.
    4. Palatable .
    5. pH 5.
    5. 3.3 to 4.0 .
    6.
    6. 1.10 g/ml to 1.30 g /ml.
    6. Weight per ml
    7.
    7. 95.0% to 105.0% of the stated amount of
    7. Assay: Ondansetron. .
    (Ondansetron 4.0 mg / 5ml )

    Remarks:
    Signature & Date:____________ Signature (QC) & Date:_____________

    02. Interim report at the beginning of Filling:

    1. Filled Volume 1. 50.00 ml to 50.75 ml.


    1.

    2. Cap Leakage Test 2. Must be leak proof.


    2.
    Remarks:
    Signature &Date:_____________ Signature (QA) & Date:_____________

    03. Final report after Packing:


    1. Batch No. 1. . 1.
    2. Mfg. Date & Exp. Date 2. Mfg. Date: & Exp. Date: 2.
    3. Price 3. 3.
    Signature &Date:_____________ Remarks:
    Signature (QA) & Date:_____________

    Checked By: ____________________ Date: ______________________

    Form No.: QA/FORM/IPC/ LFSY06 Version: 01 Effective Date: 01.06.2014


    LEON PHARMACEUTICALS LIMITED
    Satkhamair, Sreepur, Gazipur.
    Department Quality Assurance
    Title In-Process Analysis Request & Report Sheet

    Checked By: ____________________ Date: ______________________

    Form No.: QA/FORM/IPC/ LFSY06 Version: 01 Effective Date: 01.06.2014

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