Page 9 - Microbiology in workplace

GMP Training – Microbiology in the Workplace by www.gmpsop.com

Micro-organisms can rapidly multiply in the presence of stagnant water. This is
why equipment must be stored dry.

In addition, topical creams have strict limits on bio burden, since creams are
often used by patients on damaged or broken skin. If the product is
contaminated, patients may become infected.

What do the cGMPs say?

US FDA CFR 211

§ 211.67 Equipment cleaning and maintenance.

(a) Equipment and utensils shall be cleaned, maintained, and sanitized at
appropriate intervals to prevent malfunctions or contamination that would
alter the safety, identity, strength, quality, or purity of the drug product
beyond the official or other established requirements.

(b) Written procedures shall be established and followed for cleaning and
maintenance of equipment, including utensils, used in the manufacture,
processing, packing, or holding of a drug product

International GMPs

Equipment

3.34 Manufacturing equipment should be designed, located and maintained to
suit its intended purpose.

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.

3.37 Washing and cleaning equipment should be chosen and used in order not
to be a source of contamination.

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