Aseptic filling and gowning Procedure | GMPSOP

Aseptic filling and gowning Procedure

PURPOSE

To monitor viable organisms on the gloves hands, forearms, and uniforms of aseptic filling room personnel.

SCOPE

This procedure applies to the aseptic filling room personnel monitoring at the applicable plant.

RESPONSIBILITY

It is the responsibility of the Microbiology Department to conduct this SOP 

as written.

FREQUENCY

At the beginning and at the end of the aseptic filling of every production run (lot), the gloved hands of all employees engaged in filling shall be monitored. Uniforms and forearms shall be monitored once a week.

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