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Additional Facilities

  • PRODUCTION AND IN‐PROCESS CONTROLS

  • PACKAGING AND IDENTIFICATION LABELING

  • STORAGE AND DISTRIBUTION

  • LABORATORY CONTROLS

  • VALIDATION

  • CHANGE CONTROL

  • REJECTION AND RE‐USE OF MATERIALS

  • COMPLAINTS AND RECALLS

  • CONTRACT MANUFACTURER

Buildings And Facilities Process Equipment Control Documentation And Records Control

  • Documentation System and Specifications

  • Equipment Cleaning and Use Record

  • Records of Raw Materials, Intermediates, API Labeling and Packaging Materials

  • Master Production Instructions

  • Batch Production Records

  • Laboratory Control Records

  • Batch Production Record Review

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