Quality and safety at United Pharmaceuticals Inc. are governed by a formally established Quality Management System (QMS) that controls and monitors all critical operational activities. Standard Operating Procedures (SOPs), controlled documentation, and validated methodologies are implemented to ensure consistent conformance to predefined quality specifications. In-process controls, qualified analytical testing, and comprehensive batch record reviews are conducted to ensure data integrity, process consistency, and full traceability across manufacturing, packaging, and material handling operations.
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Safety controls are implemented through a structured, risk-based approach designed to safeguard products, personnel, and controlled environments. Hazard identification, risk assessment, and preventive control strategies are applied to reduce variability and maintain operational integrity.
Controlled access systems, environmental monitoring programs, and defined handling procedures are enforced to mitigate contamination risks and ensure compliance with established safety and hygiene requirements.
All quality and safety systems are aligned with applicable regulatory requirements and recognized industry standards. GMP-based controls govern document management, change control, deviation investigation, corrective and preventive actions (CAPA), and process validation activities.
Quality and safety systems are subject to continuous monitoring and periodic review to ensure ongoing effectiveness. Key performance indicators, trend evaluations, and root cause analyses support proactive system improvements. This systematic approach enables United Pharmaceuticals Inc. to maintain robust quality oversight while adapting to evolving regulatory requirements and operational demands.
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