Paradigm Change in Manufacturing Operations (PCMO)

PCMO Program of Activities:
PDA launched the project activities related to the PCMO program in December 2008 to help implement the scientific application of the ICH Q8, Q9 and Q10 series. The PDA Board of Directors approved this program in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology and Science Advisory Boards of PDA.

Although there are a number of acceptable pathways to address this concept, the PCMO program follows and covers the drug product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations. This project focuses on Pharmaceutical Quality Systems as an enabler of Quality Risk Management and Knowledge Management.

The PCMO Goal:
Using the Parenteral Drug Association's (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations Project 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 the 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.  PCMO task force members also contribute to PDA conferences and workshops on the subject.

PCMO follows the product lifecycle concept 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

All PCMO activities are categorized into the following:

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

For more individual project details see the PCMO dossier.

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

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