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Parenteral Drug Association Connecting People, Science and Regulation ®

Paradigm Change in Manufacturing Operations (PCMO®)

The PCMO® Goal

In December of 2008, the Parenteral Drug Association's (PDA) Board of Directors approved an initiative in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology and Science Advisory Boards of PDA to help implement the scientific application of the International Conference on Harmonisation (ICH) Q8, Q9 and Q10 series. The goal of the Paradigm Change in Manufacturing Operations (PCMO®) initiative is to drive the establishment of 'best practice' documents and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing ICH guidelines on Pharmaceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

The PCMO® program facilitates communication among the experts from industry, university and regulators as well as experts from the respective ICH Expert Working Groups and Implementation Working Group.  The program follows and covers the product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations.  PCMO® task force members also contribute to PDA conferences, workshops and trainings which focus on GMP elements and Pharmaceutical Quality Systems facilitated by the enablers of Quality Risk Management and Knowledge Management.

Objectives

PCMO® follows the product lifecycle concept facilitated by implementation of Quality Systems and has the following strategic intent:

  • Enable an innovative environment for continual improvement of products and systems
  • Integrate science and technology into manufacturing practice
  • Enhance manufacturing process robustness, risk based decision making and knowledge management
  • Foster communication among industry and regulatory authorities

Structure

Download the PCMO® Dossier

All PCMO® activities are categorized into the following:

  • Life Cycle Approach
  • Quality Systems
  • Process Management
  • Quality Risk Management

For individual project details and for published literature see the PCMO® dossier.

Get Involved with PCMO®

Interested in participating? If you want to contribute or have questions about any of these activities please feel free to click the button to the right or contact us by e-mail at PCMO@pda.org.

*Paradigm Change in Manufacturing Operations and PCMO® are copyrighted by PDA and should not be used without expressed written consent from PDA.