SOP for Cleaning Validation of Empty Capsule Loader

OBJECTIVE

To provide a procedure for cleaning validation of Empty Capsule Loader.

SCOPE

Covers the procedure for cleaning validation of empty capsule loader.

RESPONSIBILITY

Production chemist

Production In-charge

QA officer

PROCEDURE

• Clean the Empty Capsule Loader as per the SOP for Cleaning Procedure of Auto Loader.
• Collect the water sample from the final rinse in a clean glass apparatus (beaker /conical flask) and give it to the QC laboratory for testing (water change over.)
• The test carried out are – Description, Absence of the active ingredient.
• Record the observations.
• Inspect the equipment visually for cleanliness.

PRECAUTION

• In case of any unusual observation, stop the activity and inform the QA department.

RECORDS / SPECIMEN

Records the results in the Cleaning validation Record

REVISION HISTORY

Nil

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