Organization that provides specific cGMP service(s) according to a written contract and to mutually agreed upon conditions; services provided include manufacturing product, laboratory services, packaging and more.
Glossary
Contract Service Provider
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Ampoule (Ampule)
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HME
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Validation
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APIs
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Toxicology
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GDUFA
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Inspections
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Capsules
Microcapsule
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Wurster Process
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