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  • Cartonator DQ Observation Against DQ

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    kenjin
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    The document lists 12 observations against the cartonator design qualification (DQ) documentation. These include missing information like operation manuals, incorrect output specifications of 150 instead of 180 cartons per minute, missing carton size and dimension details, lack of layout drawings, and omitted regulatory and performance requirements. The same 12 observations are listed 3 times for the DQ documentation against DQ, ACG DQ, and ACG DQ requirements.

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    DQ obersavation 012121

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    The document lists 12 observations against the cartonator design qualification (DQ) documentation. These include missing information like operation manuals, incorrect output specifications of 150 instead of 180 cartons per minute, missing carton size and dimension details, lack of layout drawings, and omitted regulatory and performance requirements. The same 12 observations are listed 3 times for the DQ documentation against DQ, ACG DQ, and ACG DQ requirements.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    8 views3 pages

    Cartonator DQ Observation Against DQ

    Uploaded by

    kenjin
    The document lists 12 observations against the cartonator design qualification (DQ) documentation. These include missing information like operation manuals, incorrect output specifications of 150 instead of 180 cartons per minute, missing carton size and dimension details, lack of layout drawings, and omitted regulatory and performance requirements. The same 12 observations are listed 3 times for the DQ documentation against DQ, ACG DQ, and ACG DQ requirements.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    Cartonator DQ observation against DQ

    1. Page no 11/40 along with operation manual, service or maintenance manual


    should be include.
    2. Page no 23/40 Output should be 180carton/minute but they mention 150
    carton/minute. As per URS need to update.
    3. Page no 23/40 carton size length should be changed as per URS.
    4. Page no 26/40 layout shall be attached in DQ.
    5. Page no 23/40 Dimension of Equipment not mentioned in DQ against GA
    Drawing.
    6. Machine intend to use 7 to 7:30 hrs. in a shift of 8hrs. not available in DQ
    7. Non flame proof electrical panel shall be mention in DQ.
    8. Regulatory requirement of Equipment shall be mentioned for local FDA, EU-
    GMP also.
    9. Leaflet rejection % limit not mentioned in DQ.
    10. Machine performance percentage not mentioned in DQ.
    11. About camera performance mention in separate table and 21CFR not
    mentioned.
    12. List of spares not mention or not given in DQ.

    Cartonator DQ observation against ACG DQ

    1. Page no 11/40 along with operation manual, service or maintenance manual


    should be include.
    2. Page no 23/40 Output should be 180carton/minute but they mention 150
    carton/minute. As per URS need to update.
    3. Page no 23/40 carton size length should be changed as per URS.
    4. Page no 26/40 layout shall be attached in DQ.
    5. Page no 23/40 Dimension of Equipment not mentioned in DQ against GA
    Drawing.
    6. Machine intend to use 7 to 7:30 hrs. in a shift of 8hrs. not available in DQ
    7. Non flame proof electrical panel shall be mention in DQ.
    8. Regulatory requirement of Equipment shall be mentioned for local FDA, EU-
    GMP also.
    9. Leaflet rejection % limit not mentioned in DQ.
    10. Machine performance percentage not mentioned in DQ.
    11. About camera performance mention in separate table and 21CFR not
    mentioned.
    12. List of spares not mention or not given in DQ.
    Cartonator DQ observation against ACG DQ

    1. Page no 11/40 along with operation manual, service or maintenance manual


    should be include.
    2. Page no 23/40 Output should be 180carton/minute but they mention 150
    carton/minute. As per URS need to update.
    3. Page no 23/40 carton size length should be changed as per URS.
    4. Page no 26/40 layout shall be attached in DQ.
    5. Page no 23/40 Dimension of Equipment not mentioned in DQ against GA
    Drawing.
    6. Machine intend to use 7 to 7:30 hrs. in a shift of 8hrs. not available in DQ
    7. Non flame proof electrical panel shall be mention in DQ.
    8. Regulatory requirement of Equipment shall be mentioned for local FDA, EU-
    GMP also.
    9. Leaflet rejection % limit not mentioned in DQ.
    10. Machine performance percentage not mentioned in DQ.
    11. About camera performance mention in separate table and 21CFR not
    mentioned.
    12. List of spares not mention or not given in DQ.
    Cartonator DQ observation against ACG DQ

    1. Page no 11/40 along with operation manual, service or maintenance manual


    should be include.
    2. Page no 23/40 Output should be 180carton/minute but they mention 150
    carton/minute. As per URS need to update.
    3. Page no 23/40 carton size length should be changed as per URS.
    4. Page no 26/40 layout shall be attached in DQ.
    5. Page no 23/40 Dimension of Equipment not mentioned in DQ against GA
    Drawing.
    6. Machine intend to use 7 to 7:30 hrs. in a shift of 8hrs. not available in DQ
    7. Non flame proof electrical panel shall be mention in DQ.
    8. Regulatory requirement of Equipment shall be mentioned for local FDA, EU-
    GMP also.
    9. Leaflet rejection % limit not mentioned in DQ.
    10. Machine performance percentage not mentioned in DQ.
    11. About camera performance mention in separate table and 21CFR not
    mentioned.
    12. List of spares not mention or not given in DQ.

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