iSpeak Blog

ISPE QC/Analytical Community of Practice Established

Roujian Zhang, PhD
ISPE QC/Analytical Community of Practice Established

Quality Control (QC) is a vital part of CMC (chemistry, manufacturing, and controls), which ensures the quality and consistency of manufactured drug products. It involves a wide variety of analytical technologies, requires well trained analysts, and is a major component of the critical path to regulatory submissions and product release.

Given the inherent importance of QC to the pharmaceutical industry, ISPE is excited to introduce the newly launched QC/Analytical Community of Practice (CoP). The goal is to provide a forum for ISPE members to share best practices, create breakthrough ideas, and provide input to new regulations related to the application of QC in the pharmaceutical industry.

This new CoP is led by a recently formed Steering Committee comprised of seasoned subject matter experts. The Steering Committee meets monthly to discuss QC-specific topics and to update progress towards knowledge sharing projects (ISPE Guides, Pharmaceutical Engineering® Magazine articles, ISPE Training, etc.).

The CoP Steering Committee will initially focus on the following four topics:

  • Identification and investigation of out-of-specification (OOS) test results
  • Real time release
  • QC key performance indicators (KPIs)
  • Sustainability/green labs

Future topics include, for example:

  • Digital transformation, automation, future labs
  • Lab safety
  • Compendial harmonization
  • Analytical method lifecycle management
  • Method validation and method transfer
  • Lean laboratory operations (e.g., reduce non-value-added tests)
  • Contract lab management
  • Reference standards & critical reagent management
  • Rapid micro testing
  • Training (e.g., develop standard training materials/schemes across sites/companies)

Inaugural leaders of the ISPE QC/Analytical CoP Steering Committee are:

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Roujian Zhang, PhD
Evive Biotech
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Christian Scheidl
Head QC and AS&T
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Jim Seery

The QC/Analytical CoP Steering Committee is currently seeking additional subject matter experts to augment the team. For more information, please contact: