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Additional Facilities
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PRODUCTION AND IN‐PROCESS CONTROLS
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PACKAGING AND IDENTIFICATION LABELING
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STORAGE AND DISTRIBUTION
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LABORATORY CONTROLS
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VALIDATION
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CHANGE CONTROL
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REJECTION AND RE‐USE OF MATERIALS
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COMPLAINTS AND RECALLS
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CONTRACT MANUFACTURER
Buildings And Facilities Process Equipment Control Documentation And Records Control
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Documentation System and Specifications
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Equipment Cleaning and Use Record
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Records of Raw Materials, Intermediates, API Labeling and Packaging Materials
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Master Production Instructions
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Batch Production Records
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Laboratory Control Records
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Batch Production Record Review
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