Contributing Editors

1. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

2. The Transition To E-Labeling Is More Than Uploading PDFs 10/31/2025

   Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.

3. Are You Still Evaluating CMOs When You Really Need A CDMO? 10/29/2025

   Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

4. Program Manager Alignment And Integration: Best Practices When Working With A CDMO 10/23/2025

   This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

5. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

   The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

6. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

   Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

7. September 2025 — CDMO Opportunities And Threats Report 10/14/2025

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

8. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

9. Import Product Specifications And Drug Registration Testing For China 10/6/2025

   This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

10. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.