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  • CMC (Chemistry, Manufacturing, and Controls)

    The section on a BLA (Biologics License Application) or IND (Investigational New Drug) describing the composition, manufacture, and specifications of a drug product and its ingredients.

  • CMC-BWG (CMC Biotech Working Group)

    In August of 2008, company representatives from Abbott, Amgen, Eli Lilly & Company, Genentech, GlaxoSmithKline, MedImmune, an Pfizer were brought together to help advance the principles contained in ICH Q8(R2), Q9 and Q10, focusing on the principles of Quality by Design. The application of QbD to biotechnology products represents an important opportunity as the manufacturing and development of such products involves unique challenges with regard to both drug substance and drug product manufacturing due to the complexity of both the products and the biological manufacturing processes.Through a series of inter-company and regulatory interactions, the group set out to create a case study (“A-Mab: a Case Study in Bioprocess Development” – Version 2.1, October 30, 2009) that would stimulate discussion around how the core principles contained in these guidelines would be applied to product realization programs, with a multitude of ral world scenarios, as opposed to a singular approach.

  • CMCCC

    Chemistry and Manufacturing Controls Coordinating Committee (CDER)

  • CMD

  • CMD

    Count of Median Particle Diameter

  • CMDB

    Configuration Management Database

  • CME

    Continuing Medical Education

  • CMGB (CDER)

    Case Management and Guidance Branch (CDER)

  • CMHS

    Center for Mental Health Services (SAMHSA)

  • CMI

    Consumer Medication Information

  • CML

    Calibration Master List

  • CMM

    Clinical Materials Management

  • CMMI®

    Capability Maturity Model® Integration

  • CMMS

    Computerized Maintenance Management System

  • CMO

    Contract Manufacturing Organization

  • CMO

    Contract Management Office

  • CMOS

    Complementary Metal-Oxide Semiconductor

  • CMP

    Civil Money Penalty

  • CMP/HMC

    Comprehensive Medical Plan/Health Maintenance Organization

  • CMS

    Centers for Medicare and Medical Services (DHHS) (formerly HCFA)

  • CMU

    Cementitious Masonry Unit

  • CMU

    Concrete Masonry Unit

  • CMV

    Cytomegalovirus

  • CMV

    Clinical Manufacturing Verification

  • CN

    Cellulose Nitrate