Regulatory Articles

  1. Performance Test According To Chapter 2.1.7 Of The Ph. Eur. 7/21/2023

    This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

  2. Repeatability Test With External Test Weights 7/20/2023

    A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.

  3. Reduce Human Error In Healthcare Operations And Medical Equipment Management 4/20/2023

    Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care.

  4. Containment Solutions To Help Emerging Biologic Companies 3/24/2023

    Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

  5. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

  6. Biological Indicators And The European Pharmacopoeia 5/10/2022

    Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.

  7. How Digitization Is Delivering Competitive Advantage In Device Assembly 9/20/2021

    Data and the digitization of assembly equipment work to deliver a competitive advantage to pharma partners in terms of quality, continuous improvement, de-risking maintenance, and change management.

  8. Finding The Ideal Balance — Where Risk And Cost Of Quality Meet 10/6/2020

    It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

  9. Experimental Design And Positive Controls For Package Integrity 4/9/2020

    Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

  10. A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices 7/9/2019

    It has been reported that 83,000 deaths and 1.7 million injuries have been linked to medical devices adverse events over the past decade. There is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations, possibly leading to medical devices that pass FDA HFE validation yet still exhibit significant use errors when utilized in the real world. This paper explores the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework.