GMP asks the question: How do we know that the distillation equipment is operating correctly?
A well designed set of GMP documents will ensure that all aspects of the equipment are installed, operating and performing correctly along with supporting documents. This assurance gives us confidence that the distillates made by the distillation system are consistently produced and are of a uniform quality.
The manufacturer of the equipment provides a series of documents to verify that all aspects of the distillation equipment are correct and operating properly. The IQ/OQ/PQ documents are the most frequently requested.
All items must pass. If not, a deviation report must be issued, and qualification must stop until the deviation is resolved.
Installation Qualification Documents – make sure the correct equipment is received and is installed correctly.
Each part received is checked against the purchase order.
The space and location for the equipment and environment is verified.
The required utilities and chemicals are inspected.
Correct assembly of the equipment is verified.
Operational Qualification Documents – make sure that each equipment function works correctly.
Each function of the distillation equipment is checked.
Where measurements such as temperature and pressure are made, the accuracy and range of the outputs are verified.
Performance Qualification Documents – make sure that the equipment can perform it’s primary function.
Teste are performed to verify that the equipment can perform it’s primary function
Preventative Maintenance SOP
Calibration Check SOP
Packing list documents
Certificates of test equipment