Tips to Streamlining the Drug Master File Process
The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug dosage form …
Bryan Armentrout
Bryan Armentrout is an expert in dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, crisis management, and process improvement. Prior to consulting he...Greg Weilersbacher on Change Control for GMP Production Facilities
Many companies limit change control to documentation while handling equipment and facilities in isolation, but that practice can wreak havoc on GMP operations.
EAS Consultants Interviewed on FSMA Compliance for Warehouses
FDA has started inspection of food processing plants to assess FSMA implementation. Is your facility ready?