Page 24 - Cleaning and sanitation in GMP

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

International GMPs

3.36 Manufacturing equipment should be designed so that it can be easily and
thoroughly cleaned. It should be cleaned according to detailed and written
procedures and stored only in a clean and dry condition.

Prevention of cross-contamination in production

5.18 Contamination of a starting material or of a product by another material or
product must be avoided. This risk of accidental cross-contamination arises from
the uncontrolled release of dust, gases, vapors, sprays or organisms from
materials and products in process, from residues on equipment, and from

operators' clothing.

Overview

Equipment cleaning is critical to product quality. Cleaning is as much as a
technical task as formulating, so it requires the same attention to detail and
compliance to GMP.

The same principles apply for equipment cleaning as they do for facility cleaning:

Follow all written cleaning SOPs,

Maintain records of cleaning.

Use only those cleaning agents that have been approved by QA.

Store cleaning equipment in dry conditions, and clean the cleaning equipment
regularly.

With equipment, a togging system should identify the equipment cleaning status.

GOOD TO KNOW - WATER RESIDUE IN HOSES

A common problem in production areas is the cleanliness of transfer hoses.
Transfer hoses can be a major source of microbial contamination if left wet on

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