| • Location and Surroundings | • Documentation and Records | • Validation and Process Validation |
| • Building and Premises | • Labels and Other Printed Materials | • Product Recalls |
| • Water System | • Quality Assurance | • Complaints and Adverse Reactions |
| • Disposal of Waste | • Self Inspection and Quality Audit | • Site Master File |
| • Warehousing Area | • Quality Control System | • Water System, Purified Water and Water for Injections |
| • Production Area | • Specifications | • Equipment |
| • Ancillary Areas | • Master Formula Records | • Analytical Method Validation |
| • Quality Control Area | • Packaging Records | • Cleaning |
| • Personnel | • Batch Processing Records (BPR) | • HVAC |
| • Health, Clothing and Sanitation of Workers | • Standard Operating Procedure and Records | • Media Fill Test |
| • Manufacturing Operations and Controls | • Reference Samples | • Product Information |
| • Raw Materials | • Reprocessing and Recoveries | |
| • Equipment | • Distribution Records | |
