Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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38 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m drug containment and safety, discussion on the compatibility of CSTDs with biological drug products has been nascent. CSTD use may result in incompatibility issues, including vial rubber stopper coring/shedding, drug product aggrega- tion and particle formation due to lubricants or other mate- rials in the device f luid path, and inaccurate dosing due to variability in CSTD hold up volumes. When the CSTD WG was established in March 2019, the pending implementation of United States Pharmacopeia General Chapter <800> "Hazardous Drugs–Handling in Healthcare Settings" at the end of 2019 would have made CSTDs mandatory for biologics classified as hazardous by the National In- stitute for Occupational Safety and Health (NIOSH). The potential implementation of USP <800> created a critical gap in the awareness regarding technical challenges among health authorities, pharmacy/nursing associations, and device manufacturers. The CSTD WG works to inf luence the technical, clini- cal, and regulatory landscape associated with the usage of CSTDs with biologics. Within three months of conceptual- ization, the WG sponsored an Oct. 29, 2019 workshop, Use of Closed System Transfer Devices with Biologics, to review the risks and challenges associated with the use of CSTDs with biologics. Another objective was to set the stage for further dialog towards alignment on the appropriate use and implementation of CSTDs for biologics, in particular, the technical challenges and risks associated with CSTDs from a biologic compatibility and product quality perspec- tive. Regulatory agencies, pharmacists, and CSTD manu- facturers were invited to present at the workshop to ensure participation from key stakeholders (Figure 2). Resources provided through IQ (workshop organization/ funding, rapid approval of presentations and general work- shop support) enabled WG subject matter experts to focus on the science behind CSTD concerns and accomplish a goal that would have been difficult for a single company to achieve on its own. In alignment with IQ strategic objec- tives the workshop provided a neutral forum for the member companies to present a unified scientific position on CSTD use with biologics. The workshop highlighted concerns and communication gaps regarding CSTD use including: • Technical issues that impact product quality/dosing (e.g., hold-up volume variability, stopper coring) • Inconsistent/inappropriate use of CSTDs with USP <800> applied more broadly than required • Absence of proper CSTD training procedures • Healthcare providers relying on CSTD manufacturers for drug compatibility data • Absence of a universal standard for CSTD testing for biologics (e.g., ASTM standard) • Inconsistent interpretation of evolving regulations and device design inputs for biologics compared to small-molecule products. The workshop discussion made it clear that each stake- holder had differing but equally important priorities, and that Quality Collaboration Figure 1. Bio CMC Leadership Group portfolio and accomplishments. See reference section for cited references. ALL FIGURES ARE COURTESY OF THE AUTHORS.

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