Quality Assurance
Quality is Engineered, Not Just Checked
At Plexuspharmaco, Quality Assurance is not a department—it is the foundational culture that governs every decision we make. We believe that every dose manufactured in our facilities represents a promise of health to a patient.
Our global Quality Management System (QMS) ensures harmonized compliance across all manufacturing nodes, aligning seamlessly with US FDA, MHRA, EMA, and WHO guidelines.
The Six Pillars of Our QMS
A comprehensive, closed-loop approach that operates under rigorous quality systems to support product safety from active pharmaceutical ingredient (API) sourcing to post-market surveillance.
Quality Policy
Our uncompromising commitment to 'Quality by Design' (QbD) ensures that safety, efficacy, and purity are built into every product from the ground up.
Quality Control (QC)
Advanced analytical testing laboratories equipped with HPLC, GC, LC-MS/MS for rigorous raw material, in-process, and finished product testing.
Validation & Calibration
Continuous validation of manufacturing equipment, analytical methods, and cleanroom environments to guarantee reproducible outcomes.
Risk Management
Proactive FMEA and HACCP protocols to identify, mitigate, and eliminate potential quality risks before they manifest.
Data Integrity & Traceability
Fully compliant 21 CFR Part 11 digital systems ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
CAPA Systems
Robust Corrective and Preventive Action mechanisms driving a culture of continuous improvement across all operational tiers.
Post-Market Surveillance & Pharmacovigilance
Our responsibility does not end when the product leaves our facility. We maintain a robust global pharmacovigilance network to monitor the safety and efficacy of our medicines in real-world clinical settings, ensuring supports patient safety.
Quality Policy & EU-GMP Statement
Download our corporate Quality Policy, EU-GMP compliance framework, and analytical validation guidelines.