Page 16 - Microbiology in workplace

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

Overview

Objectionable organisms

Some micro-organisms are of particular concern in certain dose forms.

Objectionable organisms are organisms that shouldn't be present in a product,
because of:

Product degradant on, making products ineffective

Consumer safety, as products could become health risks

GOOD TO KNOW - REGULATORY VIEW ON MICROBIAL LIMITS

The significance of micro-organisms in non-sterile pharmaceutical products
should be evaluated by the manufacturer in terms of the following:

Use of the product (topical or oral)

Nature of the product (supports/inhibits growth)

Potential hazard to the user (children/sick/old)

It is therefore very difficult to set hard and fast regulatory limits for micro-
organisms, except for specific products.

GOOD TO KNOW - MICROBIOLOGY "FACTS" END QC LABORATORY CONTROL

It would be virtually impossible to completely validate test procedures for
every organism that may be objectionable. However, it is a good practice to

assure that inhibitory substances in samples are neutralized.

For products such as topicals, inhalants, or nasal solutions where there is
a major concern for microbiological contamination, isolates from plate
counts, as well as enrichment testing, should be identified.

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