Insights On Regulatory Compliance

1. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

   Travere Therapeutics is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

2. Why Are Feasibility Studies Important For Your Pharmaceutical Product? 5/5/2021

   A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm your process is correctly designed. The knowledge gained will help mitigate the risks before submission to regulatory agencies or Process Performance Qualification (PPQ) batches.

3. 503B Sterile Compounding Facility Goes Paperless With QMS Software 8/23/2021

   As part of its continuous improvement program to drive additional growth and increase efficiencies, QuVa Pharma sought to optimize its testing processes — aligning lab operations and quality efforts to maximize resources and minimize paper-based processes. Read how using the Manufacturing Excellence™ solution in the laboratory has significantly improved process throughput, employee proficiency, cross-functional team collaboration and quality.

4. What Is The Difference Between Verification And Validation Of Analytical Methods In The Pharmaceutical Industry? 5/5/2021

   For a contract manufacturer, one of the first steps in evaluating a technology transfer project is: do we need to perform analytical method verification or method validation? Although method verification and method validation look similar, they are not the same and actually have different requirements.

5. Key Considerations For A Successful Pharmaceutical Tech Transfer 5/5/2021

   A pharmaceutical technology transfer can also mean knowledge transfer about existing products from one manufacturing site to another by a facility change, a company merger, an acquisition, or a shift to a contract manufacturer (CMO).

6. Using Egnyte For Life Sciences As GxP Repository 1/6/2021

   Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.

7. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

   Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

8. Commercial Manufacturing In Half The Time 9/1/2021

   Due to US FDA requirements for commercial manufacturing of regulated (GMP) intermediates, a global pharma company quickly needed a dedicated production facility to produce its commercial antibiotic (carbapenem) intermediate.

9. How To Understand ASTM E2500 12/21/2020

   ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.

10. Process Characterization And Validation For Biologic Processes 4/3/2020

    Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.