Quality Assurance – Amber LifeSciences
Amber LifeSciences upholds a robust quality assurance framework, aligning processes and protocols for seamless operations. This includes comprehensive medical safety evaluations, benefit-risk assessments, and meticulous monitoring of both commercialized and investigational products. Our commitment to quality ensures that every step of our operations meets stringent standards, guaranteeing the safety and efficacy of our products for patients worldwide.
Audit Excellence
Amber prides itself on its independent and comprehensive audit program, covering internal operations, sites, and supplier networks to ensure excellence across all areas.
Quality Management System
Our Quality Management System (QMS) reflects our dedication to compliance with health authority regulations and industry standards, ensuring unparalleled quality in our processes, products, and services.
Product & Patient Safety Training
Safety Training: Amber ensures comprehensive training for all team members to understand patient safety and quality protocols deeply. Our training procedures are regularly audited to maintain excellence standards.
Regulatory Transparency
Amber LifeSciences promptly communicates inspection results, taking corrective actions to uphold top operational standards, ensuring transparency and compliance with regulatory requirements across all operations.
Product Recalls Management
Amber Lifesciences maintains a meticulous process for assessing quality issues and safety risks, guaranteeing transparent disclosure of product recall details throughout the years.
Third-Party Supplier Standards
Amber Lifesciences enforces rigorous assessments, qualification criteria, and ongoing monitoring for third-party suppliers involved in our product quality and patient safety protocols, aligning with our unwavering commitment to excellence.
The Art Of Drug Manufacturing
Understanding the intricate process of pharmaceutical drug development and manufacturing.