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    SVC Manufacturing Line Commissioning GMP

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    Vladimir Shokar
    extraktLAB offers commissioning and training services to verify manufacturing equipment is operating according to specifications under cGMP regulations. The commissioning involves two phases - factory acceptance testing conducted with the customer to ensure the equipment meets manufacturer standards, and site acceptance testing after installation to verify nothing has changed. The service includes onsite training and certification of operators on equipment operation, cleaning, sampling, and maintenance procedures. Commissioning and training is provided for extraktLAB equipment only and does not exceed three days per piece of equipment.

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    SVC Manufacturing Line Commissioning GMP

    Uploaded by

    Vladimir Shokar
    34 views2 pages
    extraktLAB offers commissioning and training services to verify manufacturing equipment is operating according to specifications under cGMP regulations. The commissioning involves two phases - factory acceptance testing conducted with the customer to ensure the equipment meets manufacturer standards, and site acceptance testing after installation to verify nothing has changed. The service includes onsite training and certification of operators on equipment operation, cleaning, sampling, and maintenance procedures. Commissioning and training is provided for extraktLAB equipment only and does not exceed three days per piece of equipment.

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    Svc Manufacturing Line Commissioning Gmp

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    extraktLAB offers commissioning and training services to verify manufacturing equipment is operating according to specifications under cGMP regulations. The commissioning involves two phases - factory acceptance testing conducted with the customer to ensure the equipment meets manufacturer standards, and site acceptance testing after installation to verify nothing has changed. The service includes onsite training and certification of operators on equipment operation, cleaning, sampling, and maintenance procedures. Commissioning and training is provided for extraktLAB equipment only and does not exceed three days per piece of equipment.

    Copyright:

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

    SVC Manufacturing Line Commissioning GMP

    Uploaded by

    Vladimir Shokar
    extraktLAB offers commissioning and training services to verify manufacturing equipment is operating according to specifications under cGMP regulations. The commissioning involves two phases - factory acceptance testing conducted with the customer to ensure the equipment meets manufacturer standards, and site acceptance testing after installation to verify nothing has changed. The service includes onsite training and certification of operators on equipment operation, cleaning, sampling, and maintenance procedures. Commissioning and training is provided for extraktLAB equipment only and does not exceed three days per piece of equipment.

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    of 2

    SERVICES

    Manufacturing Line Commissioning (GMP)

    DESCRIPTION
    extraktLAB offers the highest quality commissioning and training package on the market. The commissioning
    phase of the facility and equipment under cGMP regulation involves the verification that operations and facilities are
    working according to the specified design. The activity supports qualification efforts of the customer and gives them
    methods to verify that the equipment is suitable for the intended purpose.

    Commissioning verifies the specifications for the equipment have been met and accepted by the customer.

    Operational qualification of equipment takes place in two separate phases. The first phase is Factory Acceptance
    Testing that is typically conducted in conjunction with the customer to ensure the equipment is operating according
    to the manufacturers standards. Site acceptance testing is a verification of the factory acceptance test and often
    takes place after the equipment has been installed and verifies that nothing has changed since the equipment was
    tested at the factory.

    Phase 1: Factory Acceptance Testing


    Conducted in conjunction with the customer & ensures the
    equipment is operating according to the manufacturers
    standards.

    Phase 2: Site Acceptance Testing


    Verification of the factory acceptance test & often takes place
    after equipment installation. Verifies nothing has changed since
    the equipment was tested at the factory.

    #10-2038-rev01
    DELIVERABLES
    Onsite Training
    On Equipment with Operator Certification
    On SOP Usage with Operator Certification

    SOPs
    SOPs for Operation of Equipment
    SOPs for Cleaning
    SOPs for Sampling
    SOPs for Maintenance
    FAT (Operational Qualification)
    SAT (Installation Qualification)

    Please Note: Product is training in specialized knowledge, with


    operator certification. Is sold per piece of equipment and does not
    include equipment cost, nor is it time to certify all operators onsite.
    ADDITIONAL NOTES:
    • GMP Equipment Commissioning & Training shall not exceed 3 days and is for one piece
    of equipment. If the commissioning and training exceeds this time frame, there will be
    additional costs per day of training.
    • Additional training will be charged $2,500 USD per day (Part #80-9614).
    • Commissioning & Training is available for extraktLAB equipment only.
    • The customer is responsible for preparing the site and all personnel in advance of training
    start.

    Manufacturing Line Commissioning (GMP)

    SERVICES To Order: Part #80-9629

    651-600-0036 | EXTRAKTLAB.COM
    500 SIMMON DR. OSCEOLA, WI 54020

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