INSIGHTS ON REGULATORY COMPLIANCE

• Qualified Reference Standards: Setting The Standard For Product Quality

  Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

• Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway

  Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

• A Partner Who’s Continuous Flow Ready

  Through the combination of process optimization, modularization and automation, our continuous flow process can improve the productivity and quality of pharmaceuticals by increasing process robustness, reducing chemical waste, and making it easier and safer to handle unstable chemicals.

• Identifying And Preventing Common Data Integrity Issues

  Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate.  A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.

• Insights Into The Medical Device Single Audit Program (MDSAP)

  4/19/2022

  Learn how the The Medical Device Single Audit Program allows a single regulatory audit to satisfy the requirements of jurisdictions around the world.

• Annex 11: The EU’s New Expectations For Regulated Computerized Systems

  8/27/2021

  The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.

• Apheresis Variability Control In Cell Therapy Manufacturing

  7/25/2022

  Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.

• 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.

• Alcohols For Use As An Antimicrobial Agent

  12/1/2022

  Care must be taken when determining the use of alcohols in any controlled environment. Learn about the many useful and practical properties of alcohols along with important regulations.