Assessing the Impact of Single Use Systems on Patient SafetyELSIE’s perspective on a systematic, comprehensive approach to safety evaluation

Assessing the Impact of Single Use Systems on Patient SafetyELSIE’s perspective on a systematic, comprehensive approach to safety evaluation

03/23/2017, 11:30 AM - 12:15 PM

INTERPHEX Innovation Stage

Language:
English

Single use process technology is routinely used in the manufacture of pharmaceuticals and biopharmaceuticals. The potential for extractables and leachables from single use systems and their impact on patient safety are an important focus of drug manufacturers and regulators. While current regulatory guidelines and industry standards provide general direction on compound-specific safety assessments, they do not offer a comprehensive approach to safety evaluations of extractables and leachables. Smaller, emerging companies might not even be aware of the extent of the extractables and leachables data expected by regulatory authorities and that the FDA has issued warning letters in cases where the appropriate extractables and leachables studies were missing for a drug product. The authors will describe a comprehensive approach to determine the impact single use process technology has on patient safety.

Contributors

  • George Adams

    Speaker

    Director of Marketing, Provantage Validation Services

    Millipore Sigma

  • Thomas Broschard

    Speaker

    Associate Director, Head of Chemical Toxicology

    Merck KGaA

  • Jessica Shea

    Speaker

    Manager, Global Technical Services

    Millipore Sigma

Documents

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. The implementation of single use process technology is raising concern about drug safety. The safety concerns can be managed. 2. Regulatory guidance is unclear. There are established practices that are acceptable to regulators. 3. How can best practice be applied. An example of of best practices can be applied is used as an illustration.

Categories

  1. Track
    Enabling Technologies to Streamline Operations

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.