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SVC Manufacturing Line Commissioning GMP

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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Vladimir Shokar
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70 views2 pages

SVC Manufacturing Line Commissioning GMP

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.

Uploaded by

Vladimir Shokar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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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