08.30.26 -- AI Needs Human Oversight To Better GMP Documentation

FROM THE EDITOR

FEATURED EDITORIAL

CSV Assumes The AI System Sits Still — It Doesn't.

By Sachin Bhandari, TrustBridge Compliance

A Much-Improved Approach For Understanding And Managing Safety Risks

By Mark F. Witcher

INDUSTRY INSIGHTS

Email Etiquette That Actually Saves Time For Pharma And Biotech

Flamma

Look Back At USP <86>: Key Changes And Impact On Biological Reactivity

By Jillian Miller, Pace® Life Sciences

Tablet Edge Erosion – Solutions For Friability

Natoli Engineering Company, Inc.

CDMO Partnerships: Why Speed And Flexibility Matter Now More Than Ever

By Miguel Ángel Ortega Sánchez, ROIS

Mixing Technologies For The Production Of Low To High Viscosity Adhesives

Charles Ross and Son Company

How Automated Microscopy Systems Improve Analytical Workflows

Ensorcell

Scaling Digital Logbooks In Pharmaceutical Manufacturing

By Nishika Makwana, Tulip

Enhancing Biopharmaceutical Production Through Advanced Mixing

By Paulo Bento and Scott Patterson, ILC Dover, An Ingersoll Rand Business

Smarter CMC Strategies To Accelerate Next-Gen Biologics To The Clinic

Lonza

From Brick Dust To Breakthrough: The Power Of Enabled Formulation

AustinPx

Drug Development Plan Explained: DPP Templates And Examples

PharmaSource

Trends And Technologies Shaping The Future Of API Manufacturing

Cambrex

Small Joint Implants: A New Era With Medureon™ Bionate

dsm-firmenich

QMS Buyer's Guide: Finding The Right Fit For The Future

MasterControl, Inc.

Innovative AI Software Solutions Driving Biomarker Research Efficiency

Danaher Life Sciences

Don't Let Seals Break Your Batch: A Risk-Based Approach

Asahi Kasei Bioprocess

Lessons Learned From Containment Performance Verification Activities

Esco Lifesciences

Safely Scaling High Potency API Manufacturing

Recipharm

Asian Companies Leverage MES At Manufacturing Facilities

Koerber Pharma

Data-Driven Predictive Maintenance And Production Transparency

Siemens

Flexible Manufacturing With Adaptable Assembly And Intelligent Software

By Otto Abildgaard and Lars Keinicke Hansen, Stevanato Group

Connecting GxP Systems Without Compromising Compliance

Blue Mountain

3D Screen Printing: Breakthrough Solutions For Patient-Centric Therapies

Adare Pharma Solutions

Solving Formulation Challenges Across Modalities

Nanoform

How Digitalizing Cleaning Validation Leads To Shorter Timelines

ValGenesis

Detection Of Low-Level Bacterial Contamination Using ICR Swabs

MilliporeSigma

Process Intensification Through Downstream Connectivity

Cytiva

Catalytic Flow Process Applications In The Pharmaceutical Industry

SK pharmteco

Tank Vent Filters For Medical Water Systems

By Critical Process Filtration, TCP Analytical

The Future Of Quality And Validation With AstraZeneca's Bob Buhlmann

Tulip

The Golden Age Of Life Sciences Innovation Needs Smarter Data

Emerson

Lung Cancer Treatment By Inhaled Formulations

By Kimberly Shepard, Lonza

Supporting The Future Of cGMP Drug Product Manufacturing

AST

Inside The Cleanroom: Disinfectant Validation Demystified With Neil Simpson

Contec, Inc.

Embarking On A Successful Cleanroom Project: Conception To Delivery

AES Cleanroom Technology

Accelerate Lead Times Through Seamless External Collaboration In Quality

Veeva

What's Ahead For Medical Device Manufacturers

By Paul Spencer, dsm-firmenich

New Approach Methodologies: The Future Of Toxicology And Safety Testing

Emulate

Get Smoother Separations, Faster: Troubleshoot Method Development

Revvity Signals Software, Inc.

Pharmaceutical Technology Transfer Steps

IDBS UK HQ

Technology For Taste-Masking In Oral Antimalarial Formulations

By Dina Shorky, Alan Reader, Sangeetha Marri, et al., Mikart

All Eyes On X-Ray Inspection For Big Box Retailers

By Mike Pipe, Mettler-Toledo Product Inspection

Overcoming Excipient Risks And Challenges For Parenteral Formulations

MilliporeSigma

How Proactive Regulatory Planning Supports Improved Drug Formulation

By Rajendra Nagamalla, CorePharma

AI Implementation To Enhance Quality

By Seongil Cho, Hyeokgeon Kwon, and Kisung Shim, Samsung Biologics

Why Spray Drying Is Gaining Attention

By Dr. Richard Johnson, Upperton Pharma Solutions

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

Lonza

Manufacturing Biologics: Purification Science And Resin Applications

CAI

The Hidden Costs Of Paper Logbooks

Ecolab Life Sciences

Novel Process Indicators For Hydrogen Peroxide Decontamination

By N.P. McLeod, M. Clifford, and J.M. Sutton, Protak Scientific Ltd

How Inline Checkweighing Optimizes GLP-1 Vial And Pen Assembly

By Doug Strong, Anritsu - Product Inspection & Detection

Comparative Analysis Of Batch And Continuous Processes

Dec Group

How To Optimize Labeling In A Pharmaceutical Environment

HERMA