Newsletter | October 29, 2024

10.29.24 -- Data Quality Issues At The Heart Of The FDA's DSCSA Troubles

SPONSOR

Webinar: Implementing PIC/S Annex 1: Contamination Control Strategy with QRM Principles

Be sure to attend on November 19th as we cover the fundamental principles of contamination control, including the identification and management of contamination hazards, risk mitigation strategies, and the alignment of these strategies with QRM methodologies. Participants will gain a clear understanding of how to organize and document contamination control measures across various processes, while ensuring regulatory alignment and minimizing the risk of non-compliance.

INDUSTRY INSIGHTS

If Your Data Could Talk...

Explore two examples where data contextualization plays a critical role in a biopharma manufacturing environment, and learn how to get your data to speak the same language across different systems.

Implement A Risk-Based Approach To Safely Manufacture HPAPIs

As interest in HPAPIs as powerful therapeutic mechanisms continues to grow, drug manufacturers must design thoughtful risk-based containment strategies to protect employees and ensure safety.

Driving Continuous Improvement: Pushing Through The Barriers To Change

Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.

Virus Filtration: Regulations And Mechanisms

In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

Advancing API Development With Aseptic Manufacturing And Processing

Delve into the complexities of API sterilization, and gain insight from best practices and the critical role of expertise in maintaining sterile production environments.

Implement Solvent Recycling To Reduce Waste And CO2 Emissions

Creating a greener manufacturing platform that accommodates solvent recovery and recycling requires careful consideration of your resources, procedures, and partnerships to achieve cost-effective goals.

Meet The Demand: Doubling Capacity At Two 503(b) Manufacturing Sites

503B compounders require special attention to maintain cGMP and regulation compliance. Examine the process for designing and managing new facilities for sterile and parenteral injectable manufacturing.

Small Scale, Big Impact: The Advantages Of Flexible Pilot Plant Equipment

Discover the benefits of flexible pilot plant equipment. Seamlessly scale up your processes, optimize your formulations, and save costs with in-house small-volume production.

Less Mess, Less Stress, Best Expressed: A Superior Alternative To Spray Drying

Although well-established processes, spray drying and hot-melt extrusion can be outperformed in terms of bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

Switching From Vials To PFS And Intravenous To Subcutaneous Formulations

Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

Vibration Isolation For Enclosures

In analytical environments, precise weighing takes place inside containment where powders do not escape. Read on to examine the effectiveness of three vibration isolation strategies.

Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach

Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry to ensure product quality and compliance.

Giving Production A Powerful Boost Through Digital Inline Printing

Gain insight into how technology is helping one company reduce aluminum foil consumption in blister production by 30 percent while maximizing efficiency.

FEATURED EDITORIAL

Data Quality Issues At The Heart Of The FDA's DSCSA Troubles

Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

SOLUTIONS

Self-Contained Biological Indicator For Monitoring Steam Sterilization

Lab-Scale High Voltage Leak Testing System For Glass Vials And BFS

Autoinjector For Deep Intramuscular Delivery

Pharmaceutical Cleanroom Pre-Engineering And Pre-Construction Services

Reducing Errors With An Innovative HPLC System

Optimizing Laboratory Development Of Synthesis To Improve Yields

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