Page 27 - Cleaning and sanitation in GMP

GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com

when companies handle potent or toxic drugs, equipment cleaning validation
becomes a very important

Cleaning validation:

defines the products that can be made in the equipment

determines the maximum time allowed before the tank must be cleaned

defines the cleaning agent to use, and its correct volume and concentration

verifies the temperature of the cleaning process

verifies the length of time needed for cleaning

Cleaning and sanitizing validation verifies that the specific cleaning procedure,
under the specific conditions of cleaning described in the procedure, will be
effective for a specific range of products in specific equipment. Any changes to
these parameters may make the cleaning/sanitizing ineffective.

GOOD TO KNOW - ORIGIN OF CLEANING VALIDATION

The focus on cleaning validation commenced in the early 1990s, when the FDA
published the Inspection Guide to Cleaning Validation.

This guidance was prompted by the increased manufacture of potent and new
biotechnology products, that had high potency in low concentrations. Clearly

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