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.
New tools and policies aim to support more complex manufacturing processes.
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.
Fifty years after the man walked on the Moon, space-based science is benefiting Earth.
Advanced Discharge Systems by Ross are built with mechanisms to fit almost any high-viscosity application and increase efficiency following the mixing process.
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.
A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.
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.
The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
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.
Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.
Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
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