Quality Control

INSIGHTS ON QUALITY CONTROL

Ensuring Compliance For Virtual And Hybrid Pharmaceutical Companies
Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.
0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO
CDMO guide on environmental monitoring, media fills, and QC to prove sterility assurance in aseptic manufacturing—key elements of the Contamination Control Strategy beyond facility design.
Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

AI Enabled Pharmaceutical Cocrystal Screening
9/3/2026

Cocrystal candidate screening is resource-intensive and prone to gaps. This paper examines how AI-based modeling, trained on more than 20,000 data points, can sharpen candidate prioritization without sacrificing scientific rigor.
How To Use Enzyme Indicators In An Aseptic Production Environment
6/30/2026

Discover how transitioning to quantitative validation data allows engineering teams to optimize decontamination timelines, slash system downtime, and minimize product carryover risks.
503A Vs. 503B: Turning Regulatory Complexity Into Practical Compliance
4/20/2026

Navigating human drug compounding requires aligning Section 503A and Section 503B operations with cGMP expectations, robust quality management systems, and standing inspection readiness.
QC In The Whole Genome Sequencing Library Preparation Workflow
3/19/2026

Take a look at how electrophoresis systems differ in sizing accuracy and why those distinctions matter for assessing high‑molecular‑weight DNA and protecting QC checkpoints across sequencing workflows.
Enhancing Safety In Drug Substance Synthesis: A Smart Approach To Chemical Design
5/6/2026

Discover how safety‑by‑design principles in chemical synthesis help control exothermic reactions, reduce scale‑up risk, and enable safer, more reliable manufacturing of complex drug substances.

Rapid, Reliable, And Fully Automated Microbial QC

The Growth Direct® System is a fully automated microbial quality control platform designed for pharmaceutical manufacturing facilities with high sample throughput.
The Help You Need- Available Where And How You Need It

Flexible lab equipment services covering maintenance, repair, qualification, and validation to improve reliability, compliance, and operational efficiency.
Intuitively Simple HPLC System

This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.
Test Method Development For Package Integrity Testing

A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
Scale GMP Operations Across Sites

Blue Mountain Regulatory Asset Manager (RAM) helps life sciences manufacturers standardize maintenance, calibration, and asset workflows across sites in one validated platform.