Featured Pharma Online Editorial

1. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

2. Recent Developments Identifying Interactive Factors Affecting Tablet Scuffing Seen In The Aqueous Film Coating Process 4/16/2025

   There are three primary root causes of tablet scuffing during the aqueous film coating process, and titanium dioxide plays a role. The author provides recommendations for addressing it.

3. Growth And Trends In Topical Drug Contract Manufacturing 2/14/2025

   Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.

4. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

5. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

   Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

6. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

   Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

7. Oral Solid Dosage Formulation And Process Development: A Case Study 12/4/2024

   This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

8. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

   The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

9. Enteric Coatings For Oral Solid Dosages: A Short Guide 11/19/2024

   Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.

10. A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence 11/13/2024

    Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.