The PCMO goal

Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations (PCMO) 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).

This project 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.

Objectives

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

Structure

All PCMO activities are categorized into the following:

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

For details see the PCMO dossier

PCMO History

The PCMO is a member driven activity; PDA launched the activities related to the PCMO project in December 2008 to help bring science to the enhanced paradigm. The PDA Board of Directors approved this program in cooperation with the Regulatory Affairs and Qualiyt Committee, Biotech, Program and Science Advisory Boards of PDA. There are a number of acceptable pathways to address this concept; however the PCMO will follow and cover the drug product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations. This project will focus on Pharmaceutical Quality Systems as an enabler of Quality Risk Management and Knowledge Management.

Interested in participating? If you want to contribute or have questions about any of these activities please feel free to contact us by e-mail at PCMO@PDA.ORG.

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