ALS Global capabilities (Pharmaceutical)

Význam tématu

Reliable pharmaceutical testing and analysis ensure the safety, efficacy and regulatory compliance of drug products. A global, quality-driven laboratory network supports critical decisions in QA/QC and product development.

Cíle a přehled studie / článku

This document presents the global pharmaceutical testing capabilities of ALS, covering its company profile, quality systems, service portfolio and technical infrastructure.

Použitá metodika a instrumentace

• Chromatography: HPLC (UV-Vis, DAD, RI, fluorescence), LC-MS, GC, GC-MS, Ion Chromatography
• Elemental analysis: ICP-MS, ICP-OES, ICP-SFMS, AAS
• Spectroscopy and other techniques: FTIR, UV-Vis spectrophotometry, TOC analyzers, Karl Fischer titration, conductivity, refractive index
• Physical tests: dissolution, hardness, disintegration, friability, dimensions, sub-visible particles
• Microbiology: TAMC, TYMC, endotoxin (LAL), sterility (membrane filtration, direct inoculation), microbial ID by sequencing
• Stability: ICH-compliant stability chambers, photostability testing
• Data management: cGMP and FDA 21 CFR Part 11-compliant LIMS, WebTrieve™ portal

Hlavní výsledky a diskuse

ALS operates in over 65 countries with 350+ locations and 15 000+ staff, processing more than 40 million samples annually. Its safety performance shows a declining LTIFR trend and a Positive Performance Indicator score of 91 %. Regular audits (100+ per year) and certifications (GLP, GMP, ISO 17025) demonstrate robust quality and compliance.

Přínosy a praktické využití metody

Clients gain access to an extensive service range and local expertise combined with global technical leadership. Custom reporting formats, electronic data delivery and an online portal facilitate rapid decision-making and supply chain management.

Budoucí trendy a možnosti využití

Future directions include automation of workflows, advanced data analytics with AI, expanded multi-element and trace analysis, remote monitoring, digital sample tracking, and deeper integration of LIMS with enterprise systems.

Závěr

ALS provides a comprehensive, quality-centered platform for pharmaceutical testing, offering regulatory-aligned methodologies, advanced instrumentation, and global support to ensure reliable analytical outcomes.

Reference

• No external references were provided.