Industry Insights

1. Laboratory Glassware Washer Validation Benefits Go Far beyond Compliance 8/23/2016

   To appreciate how labwasher cleaning validation can help your organization, it helps to take a bird’s eye view of its objectives.

2. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

3. Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections 12/20/2023

   Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

4. 5 Key Questions On Implementing Pharma 4.0™ Solutions For Fill-Finish 12/1/2025

   Pharma 4.0 leverages IoT, AI, and automation to enhance drug quality. Evaluate your fill-finish line readiness by considering five key questions on modularity, high-risk process automation, and data integration.

5. Scaling Up Your Methods With USP <621> - Part 2: Hardware 9/22/2023

   Learn about the hardware changes that allow for scaling and modernization of chromatographic methods and how mismatching particle size and liquid chromatographic systems can result in poor performance.

6. The Current Trends Driving Liquid Dose Pharmaceuticals 3/1/2017

   New compounds, delivery methods, safety and security are the current trends driving liquid dose drug manufacturing. 

7. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

   Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

8. 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement 1/6/2021

   This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

9. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

   Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

10. An Analysis Of MHRA's Latest Annual GMP Inspection Deficiencies Report 1/11/2021

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019.