INSIGHTS ON REGULATORY COMPLIANCE

  • Demystifying Performance Testing: Strategies To Qualify Combination Products

    Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

  • Downstream Processing Of Biosimilars: Evolving Challenges And Considerations

    Future evolutions in the biosimilar regulatory pathway will require biosimilar manufacturers to ask several critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.

  • Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

    Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

  • Using Egnyte For Life Sciences As GxP Repository

    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.

REGULATORY COMPLIANCE SOLUTIONS

  • Powder Transfer Process

    EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. 

  • FD&C 503B

    Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset. The experienced scientists, engineers, and staff at Pii pride themselves in solving challenging problems, it is part of our DNA.

  • Pharmaceutical Asset Management & Reliability Services

    Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.

  • Quality, Compliance, And Regulatory Services For Life Sciences

    The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

  • GxP Document Management For Life Sciences Guide

    Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.