Page 3 - Microbiology in workplace
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GMP Training – Microbiology in the Workplace by www.gmpsop.com
Medicine is taken when a person isn't well, has a disease or infection, or has a
problem with their immune system. These conditions make people more
vulnerable to microbial infection, and therefore, consuming products that have
contamination may make them sicker.
We do know, though, that certain products are more at-risk than others. For
example, sterile products must have zero-allowed bio burden; topical and
intranasal products may only have low bio burden; and oral liquids and dry solid
products have less restricted bio burden.
The cGMPs also require manufacturers to keep potential bio burden
contamination below very strict levels.
What do the cGMPs say?
US FDA CFR 211
§ 211.113 Control of microbiological contamination.
(a) Appropriate written procedures, designed to prevent objectionable
microorganisms in drug products not required to be sterile, shall be
established and followed.
(b) Appropriate written procedures, designed to prevent microbiological
contamination of drug products purporting to be sterile, shall be established
and followed. Such procedures shall include validation of any sterilization
process.
International GMPs
5. Production – General
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