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Audit Topics
System Details ICHQ7 Good Manufacturing Guide Reference BioSpectra Documents Provided During Audit
Quality Assures overall compliance with cGMPs and internal procedures and specifications
  • Section 2, Quality Management
  • Section 3, Personnel
  • Section 6, Documentation and Records
  • Section 13, Change Control
  • Section 14, Rejection and Reuse of Materials
  • Section 15, Complaints and Recalls
  • Section 16, Contract Manufacturers (including laboratories)
  • Deviation Procedure and list
  • CAPAs (corrective and preventative action)
  • OOS issued list
  • Investigation Procedure
  • Change Control Procedure and List
  • Equipment
  • Customer Notification
  • Compliant/Recalls
  • Quality Manual
  • Annual Product review
  • Training
  • Internal/External Audit Schedule
  • Organizational Chart
  • Job Description
  • Documentation- SOPs
  • GMP Manufacturing
  • SOP Index
  • Stability data/Reports
  • FDA Registration/Inspection Report
  • Supplier Approval Program
  • Service Provider Approval Program
  • Instrument Calibration
  • Method Validation
Facilities & Equipment Includes activities which provide an appropriate physical environment and resources used in production
  • Section 3, Personnel
  • Section 4, Buildings and Facilities
  • Section 5, Process Equipment
  • Section 6, Documentation and Records
  • Master Validation Plan
  • Equipment Preventative Maintenance
  • Equipment Calibration
  • Equipment Cleaning
  • Equipment Qualification
  • Building/Facility Management
  • HVAC System
  • Air/Water
  • Pest Control
  • Environmental Monitoring
  • Subcontracting Policy
  • Facility Tour
  • Waste Handling
Materials Includes measures and activities to control starting materials, intermediates, and containers. It includes validation of computerized and inventory control processes, storage and distribution controls
  • Section 3, Personnel
  • Section 4.3, Water
  • Section 6, Documentation and Records
  • Section 7, Materials Management
  • Section 10, Storage and Distribution
  • Materials Management and Material control
  • Raw Material Receipt and Approval
  • BSE/TSE
  • Rejected Material
  • Cross Contamination
  • Material flow/personnel
  • Animal Origin/ Use of derived materials
  • Shelf Life Validation
  • Inventory management
Production Includes measures and activities to control the manufacture of materials, including in-process sampling and testing, and process validation.
  • Section 3, Personnel
  • Section 6, Documentation and Records
  • Section 8, Production and In-process Controls
  • Section 12, Validation
  • Batch Records (Issue/review/release)
  • Process Logbooks
  • Packaging and labeling
  • Cleaning Procedures
  • Gowning Requirements
  • Equipment Calibration
  • Process Validation for specific product
Additional Topics to Discuss
System Details ICHQ7 Good Manufacturing Guide Reference
Packaging & Labeling Includes measures and activities that control the packaging and labeling of intermediates and API’s
  • Section 3, Personnel
  • Section 6, Documentation and Records
  • Section 9, Packaging and Identification Labeling of APIs and Intermediates
  • Section 17, Agents, Brokers, Traders, Distributors, Re-packers, and Re-Labelers
Laboratory Control Includes measures and activities related to laboratory procedures, testing, analytical methods development and methods validation or verification, and the stability program
  • Section 3, Personnel
  • Section 6, Documentation and Records
  • Section 11, Laboratory Controls
  • Section 12, Validation