Newsletter | December 17, 2025
TOP 10 FROM THE EDITOR
1.
Gedatolisib Shatters Phase 3 Goals and Scales For Breast Cancer Breakthrough
2.
Roll Call In The Oral GLP-1 Race
3.
10 Ways To Strengthen U.S. API: Part I
4.
Extreme Weather Is Testing Pharma's Resilience — Is It Ready?
5.
Reimagining Psychedelics: Mental Wellness Without the Roadblocks
6.
Can AMTs Make U.S. Pharmaceuticals Faster, Better, Stronger?
7.
From Lab to Plant: Managing Operational Environment During Scale-Up
8.
The 3 Big Barriers To AMT Implementation
9.
3 [Potential] Solutions To A More Resilient Supply Chain
10.
Eco-Friendly HBL: Cheaper, Cleaner, And Ready For Pharma
TOP 10 GUEST COLUMNS
EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance
By Peter H. Calcott, Ph.D., FRSC, president and CEO, Calcott Consulting LLC
Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities
By BioPhorum
AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
By Ajaz S. Hussain, Ph.D., independent pharmaceutical regulatory science expert
Minimizing The Impact Of Human Errors Using Relational Risk Analysis
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert
How AI Is Revolutionizing Quality Management Systems
By Stephanie Gaulding, CQA, CGP, managing director, Pharmatech Associates
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
By Andrew Walsh, Thomas Altmann, Joshua Anthes, et al.
Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards
Audit Trail Compliance And What To Look For In Mitigation Software
By Sakthivel Thangaiyan
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
By Jesper. M. Wagner, NIRAS
Trust But Verify: Validating AI In Pharma's GxP World
By Sindhuri Korrapati, Intuitive Surgical
TOP 10 INDUSTRY INSIGHTS
PUPSIT As Part Of A Contamination Control Strategy (CCS)
By Cytiva
ICH Q10 Guideline Checklist
By Ideagen
GMP Annex 1 For Sterile Manufacturing In The EU
By Jubilant HollisterStier
What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?
By AST
Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance
By Particle Measuring Systems
21 CFR Part 11 Data Management Is The Basis Of Data Integrity
By Anritsu - Product Inspection & Detection
Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation Process
By Ecolab Life Sciences
The Importance Of Operator Equipment Training
By CAI
Continuous Manufacturing: An Evolving Technology For Drug Manufacturing
By Cambrex
Steps For Proper Cleaning Validation
By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin
TOP 10 SOLUTIONS
cGMP Facilities For Pharmaceutical Manufacturing
Dec Group
Blow/Fill/Seal Packaging System
Weiler Engineering, Inc.
Container Closure Integrity Testing Using Gas Ingress
Lighthouse Instruments
Rapid Sterility Testing: Actionable Results In Less Than 5 Hours
Thermo Fisher Scientific Bioproduction
IDBS PIMS And Regulatory Compliance
IDBS UK HQ
Optimize Your Contamination Control Strategy
Ecolab Life Sciences
Container Closure Integrity Testing Systems For Drug Manufacturing
Nikka Densok USA, Inc.
An Introduction To Validation Of Aseptic Fill/Finish And Related Processes
Mesa Laboratories
Environmental Monitoring For Aseptic Filling Operations
AST
Digital Production Records For Modern Manufacturing
MasterControl, Inc.
