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