Cleaning validation

Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the

microbial attributes.^[1]^[2] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by residues from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a good manufacturing practice

requirement.

The U.S.

therapeutic dose and organoleptic levels.^[4]^[5]^[6]

References

S2CID 53093674
.

PMID 1432455
.

^ International Society of Pharmaceutical Engineers, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. August 2020. ISBN 978-1-946964-31-1 ^{[full citation needed]}

PMID 8846061
.

ISSN 0147-8087. INIST 2430841. Archived from the original
on 2014-06-10.

^ FDA guidance Validation of Cleaning Processes^{[full citation needed]}

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Retrieved from "https://en.wikipedia.org/w/index.php?title=Cleaning_validation&oldid=1179322236"

[:0-1] S2CID 53093674
.

[2] PMID 1432455
.

[3] International Society of Pharmaceutical Engineers, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. August 2020. ISBN 978-1-946964-31-1 ^{[full citation needed]}

[4] PMID 8846061
.

[5] ISSN 0147-8087. INIST 2430841. Archived from the original
on 2014-06-10.

[6] FDA guidance Validation of Cleaning Processes^{[full citation needed]}

[1]

[2]

[4]

[5]

[6]

See also

References