Quality risk management plans provide identified actions to
ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
TaskMate Robotic Systems from ESS Technologies now integrate Fanuc America’s new line of selective compliance assembly robot arm (SCARA) robots to create an ultra-compact robotic cell that integrates with cartoners, case packers, and monoblock filler/cappers for collation and machine loading and unloading.
UniFlow FM Fume Hoods by HEMCO Corporation are designed for synthesis, distillation, and other reactor or rack type operations where tall apparatuses are used, or large diameter equipment is rolled into the work area.
The Allen-Bradley Kinetix VPH hygienic servo motors and the stainless-steel version of the PanelView Plus 7 graphic terminal by Rockwell Automation both work to minimize contamination during production and ease compliance.
Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.