Featured Pharma Online Editorial

1. Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges 4/30/2026

   Psychedelic therapies have shown promise in treating mental health disorders, but it will take close collaboration and cooperation of all related agencies and manufacturers to make this promise a reality.

2. A 5-Step Foundation For Early CQV Involvement 4/28/2026

   All too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and are entirely avoidable with proper planning.

3. Fostering A Quality Software Culture 11/24/2025

   Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?

4. 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.

5. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

6. Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials 3/4/2025

   Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.

7. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

   Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

8. A Look At Pharmaceutical Inspection Machine Advanced Technologies 2/7/2025

   Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.

9. 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities 8/1/2024

   A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.

10. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.