Featured Pharma Online Editorial

1. 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.

2. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

   When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

3. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

   In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

4. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

   Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

5. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

   More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

6. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

   The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

7. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

   The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

8. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 8/30/2024

   Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

9. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

   The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

10. 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.