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Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
FMEA fast & professional for GMP/cGMP projects: Step-by-step learning with colored content, templates and case studies

FMEA fast & professional for GMP/cGMP projects: Step-by-step learning with colored content, templates and case studies

Paperback

Medical Reference

ISBN13: 9798884082373
Publisher: Independently Published
Published: Mar 7 2024
Pages: 78
Weight: 0.22
Height: 0.16 Width: 5.50 Depth: 8.50
Language: English
Failure Mode and Effects Analysis (FMEA) is a structured process for identifying potential risks and defects of a product or process. This can be used during the development phase, but also during any update or evaluation.
In the quality assurance of sterile production in the pharmaceutical industry, one is forced to analyze every risk area/process. Precisely because of the new EU-GMP Annex 1 of 2022, QA specialists are forced to evaluate more processes according to contamination risk. Through the FMEA, the risks can be defined very quickly and a measure can be determined as required.

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Bayegi, Parviz

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Medical Reference