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. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

   The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

9. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

   In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

10. Breeze Through Surprise Audits — Take These 5 Actions Now 6/8/2023

    Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.