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Process Validation Stages process design

In Process Validation the first stage out of three stages is Process Design. Following are some of the points which are taken into consideration during process design. So let us check it out one by one:

To design process follow good manufacturing practices.

Uses scientific principles as well as scientific methods.

Conduct the internal review , the document decisions and the justification of the controls.

Find out critical quality attributes during process design.

Critical material attributes are defined.

Critical process parameters are also evaluated.

Also take into account the functionality of the equipment as well as the limitation of the commercial manufacturing equipment.

Also consider about the environmental conditions during process design.

Different component lots during manufacturing process.

Production operators during manufacturing process.

Use the models of pilot scale or the laboratory models design as a representative of the commercial process.

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