ALS Global capabilities (Pharmaceutical)

Importance of Topic

Global pharmaceutical testing laboratories play a critical role in ensuring drug safety, efficacy and regulatory compliance. Reliable analytical services underpin quality control at every stage of drug development and manufacturing, safeguarding public health and facilitating global market access.

Objectives and Overview of ALS Pharmaceutical Services

ALS Pharmaceuticals aims to deliver a full suite of analytical and microbiological tests to support raw material qualification, in-process monitoring, finished product release and stability studies. With origins dating to 1863, the company now operates over 350 locations in more than 65 countries, handles 40 million samples annually, and maintains revenues above USD 1.6 billion. Core objectives include method validation, batch release testing, compliance with GMP/GLP, and continuous innovation in service delivery.

Methodology and Used Instrumentation

ALS employs internationally recognised pharmacopoeial and customised analytical protocols. Key instrumentation:

• HPLC with UV-Vis (dual λ), PDA, RI and fluorescence detectors
• GC and GC–MS (headspace, FID, TCD, MS detectors)
• ICP-OES, ICP-MS and high-resolution ICP-SFMS for elemental analysis
• Atomic absorption spectroscopy, FTIR, Karl Fischer titrators, TOC analyzers
• LAL endotoxin testing (gel clot, turbidimetric, kinetic chromogenic)
• Microbiological workstations for bioburden, sterility, PET and disinfectant efficacy per USP, EP, JP and ISO standards
• Validated stability chambers covering ICH climatic zones I–IV and photostability chambers

Main Findings and Discussion

Safety performance metrics show a reduction in Lost Time Injury Frequency Rate from 2.10 to 1.00 per million hours worked over five years, alongside a 91 % Positive Performance Indicator. Method validation capacity exceeds 100 projects aligned with ICH Q2(R1), USP <233> and Ph.Eur. 2.4.20. Participation in proficiency schemes (EDQM, Pharmassure, ILPT) demonstrates consistent accuracy and traceability of results across global sites. Integrated HSE management ensures adherence to ISO 14001, OHSAS 18001 and local regulations.

Benefits and Practical Applications

ALS’s global platform offers:

• End-to-end support from method development through routine batch release
• Regulatory-compliant testing across major pharmacopoeias and ICH guidelines
• Secure, cGMP and FDA 21 CFR Part 11-compliant LIMS with Webtrieve™ real-time data access
• Local market knowledge alongside centralized technical expertise
• Comprehensive environmental and safety programs supporting sustainable operations

Future Trends and Possibilities

Emerging opportunities include adoption of artificial intelligence for data analysis, expanded use of high-throughput screening and miniaturized assays, integration of process analytical technology (PAT) in continuous manufacturing, and implementation of greener analytical methods. Enhanced remote monitoring and predictive quality control will streamline laboratory workflows and support real-time decision making.

Conclusion

ALS Pharmaceuticals combines extensive global infrastructure, advanced instrumentation and robust quality systems to deliver reliable analytical and microbiological services. Continued investment in digital platforms, sustainability and technical innovation will reinforce its position as a preferred partner for pharmaceutical testing and regulatory support.