Qualification batches are batches that are manufactured in order to qualify a process, API, or excipient according to a protocol that was developed and authorized.
Glossary
Qualification batches
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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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