Newsletter | June 26, 2025

06.26.25 -- The 3 Phases Of QRM – An Inspector's View

INDUSTRY INSIGHTS

Cost-Effective Strategies For Sterile Injectable Outsourcing

Explore how CMOs are playing a pivotal role in enabling pharmaceutical companies to optimize their operations and how this collaboration is reshaping the future of pharmaceutical manufacturing.

Neuroinflammation In Alzheimer's Disease Pathway

Recent research highlights neuroinflammation's role in AD progression, which suggests immune modulation as a potential therapeutic strategy. Learn more about neuroinflammatory processes.

Adapt Or Fail: The Urgency Of Pandemic Preparedness

A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.

A Cost-Effective Approach To Cleaning Validation And Verification

From fully developed large-scale manufacturing and packaging to a single development batch, a contract services organization must be prepared to handle multiple compounds in the same facility.

Immediate Benefits Of Real-Time Microbial Monitoring

Airborne microbial contamination is a serious concern for companies producing medicines and biotech products, and it must be addressed to ensure that products and people are kept safe.

Dynamic Precision Weighing Challenges And Innovations

Effective precision weighing systems enable users to balance product throughput, center distance, and standard deviation. Uncover key considerations in this technology's development and weighing methods.

Embrace A Contract Manufacturer Partnership That Drives Sustainability

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

Particle Engineering For Inhalation Drug Delivery

Discover key parameters for choosing the right particle engineering approach to meet dry powder inhaler (DPI) target product profiles for inhalation-based drug products.

Meeting Annex 1: A Proactive Approach To Regulatory Compliance

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the revision to the EU GMP Annex 1.

Strategies And Tools For Efficient Enantiomer Separations

Watch an overview of how different strategies and methods are employed to characterize samples containing chiral compounds.

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

Gain insight into how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

Water Activity: A Better Approach For Lyo Moisture Determination

Find out why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It

Thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.

FEATURED EDITORIAL

The 3 Phases Of QRM – An Inspector's View

Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

SOLUTIONS

Blow/Fill/Seal Packaging System

Comprehensive Regulatory Support

Solid Form Services

Analytical Method Development And Validation

Good Clinical Practice

Capacity Update April 2025: Small Molecule

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

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