Newsletter | October 15, 2024

10.15.24 -- Computer Systems Validation Pitfalls: Methodology Violations

SPONSOR

Pressure Testing Your Readiness To Ensure GMP Batch #1 Success

How can you ensure the success of your first GMP batch? In this webinar, get insights from an industry-leading CDMO expert on how to get it Right the First Time. Discover the critical tech transfer approaches that are key to the success of your API manufacturing program. Learn about critical factors, challenges, and tech transfer methodology to ensure right-first-time readiness and success. Watch here.

INDUSTRY INSIGHTS

Optimizing Cleaning And Disinfection As Part Of An Effective CCS

Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

FDA And ISO Compliance For Pharmaceutical Manufacturers

Gain essential regulatory insights to ensure the production of compliant, safe, effective, and high-quality pharmaceutical products, and explore how digital tools can streamline compliance.

The Track And Trace Guide: Building An Effective Program

Review the purpose, technology, and functionality of track and trace in the pharmaceutical manufacturing and production process.

The Importance Of 503B Facilities In Drug Manufacturing Today

Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.

Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

The Shift Toward Western Pharmaceutical Manufacturing

Delve into the complexities of securing and de-risking pharmaceutical supply chains in light of vulnerabilities and prompting renewed conversations about reshoring production.

Determining Mechanical And CCI Performance

Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to revolutionize cold storage practices.

Protecting Human Health With Organ-On-A-Chip Technology

Explore compelling evidence that suggests Organ-on-a-Chip technology offers a far more reliable means of predicting drug toxicity than traditional animal models.

The Impact Of Instrument Characteristics On USP Assay Method Migration

To evaluate the impact of different systems on the USP monograph for azithromycin organic impurities, the organic impurities monograph was tested across multiple chromatographic systems.

Add mRNA Capacity – Flexibly

Discover a platform that addresses five critical pain points to help mRNA manufacturers flexibly scale while improving the digital maturity of their sites.

Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing

Learn about an offering designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

Specialized Expertise For Efficient Management Of Clinical Supply Budgets

A financial project analyst (FPA) plays a critical role in clinical trial supply and budget management. Explore how sponsors can benefit from having this specialist on their supply partner's team.

Leveraging High-Pressure Sterile Filtration To Accommodate Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

FEATURED EDITORIAL

Computer Systems Validation Pitfalls, Part 1: Methodology Violations

When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

SPONSOR

Webinar: GxP Compliance - Leveraging Trusted Suppliers in Your Digital Transformation

In the constantly changing technology landscape, biopharma companies must ensure systems that support GxP-regulated activities are compliant with regulations such as FDA 21 CFR Part 11 and EudraLex Vol. 4 Annex 11. Achieving compliance can be costly and time-consuming. Join us on October 30th to learn how partnering with a supplier experienced in the GxP-regulated space can mitigate risk and reduce your compliance burden.

SOLUTIONS

Environmentally Controlled Stability Storage And Testing Solutions

Fast-Track Your Path To Commercialization

Ajinomoto Bio-Pharma Services Capacity Update July 2024: Fill/Finish

Cartridges For Use In Drug Delivery Applications

PBPK Predictive Modeling Services

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