Quality Control

INSIGHTS ON QUALITY CONTROL

HPLC Autosampler Performance I: Challenging USP Methods
In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.
LYO Cycle Development Ensures Success For Oncology Drug Scale-Up
An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.
Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation
Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.
Isokinetic Sampling In Unidirectional Flow
Accurate cleanroom particle monitoring requires precise isokinetic sampling. Understand how to maintain sampling accuracy and meet regulatory airflow requirements for your facility.

Aseptic Filling Quality Through Precision
3/20/2026

Precise measurement shapes every reliable workcell. Meet Andrew, a specialist who verifies components with micron‑level accuracy, ensuring each piece is built to perform exactly as designed.
A CDMO's Take On Psychedelic Formulation
1/26/2026

Psychedelics show therapeutic promise, but face major formulation and regulatory hurdles. Advances in delivery and neuroscience may unlock new mental‑health treatments.
Brewed To Perfection: How Lab Filtration Supports QA In Brewing
3/5/2026

Reliable lab workflows are essential for producing consistent, safe, high‑quality beer. Key testing steps depend on filtration, and choosing the right devices can significantly improve efficiency.
Leachables Method Development, Validation And Relevant ICH References
5/16/2025

It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
The Hidden Cost Of Tracking Requalification On Paper
8/3/2026

Uncover the hidden compliance risks of tracking inspector qualifications on paper and learn how automated tracking ensures continuous audit readiness across all operations.

Cell Therapy Selection Guide: Connected From Activation To Expansion

Active bead release gives manufacturers precise control over T cell isolation timing, phenotype preservation, and workflow efficiency, eliminating multi-day passive dissociation delays.
Asset Performance Management

Blue Mountain RAM® delivers built-in Asset Performance Management (APM) capabilities that help GMP-regulated organizations monitor equipment health, detect risk trends, and optimize performance — without sacrificing compliance.
Software For Trusted And Efficient Data Recording

Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.
Particle Loss Studies

Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.
FlexUP Technology Renewal Program

Are you using obsolete or aging instruments simply because they continue to work? Running your laboratory with outdated technology brings about challenges beyond just headaches. Older technology may limit your performance, increase your costs, and open your lab up to risk. It may be time to investigate the real cost of using obsolete technology.

With the Waters FlexUP Technology Renewal Program, always work with the latest technology for optimum productivity and security.