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PDA: Enabling Pharmaceutical Manufacturing Today

by Rich Levy, PDA, Debbie Goldstein, PDA | May 01, 2017

PDA has a long tradition of providing the scientific foundation to facilitate the technological developments that advance pharmaceutical and biotechnological manufacturing and, in so doing, benefit the public health.

The vocations of many of our members reflect manufacturing-related activities, such as supply chain, cleaning and disinfection, glass handling and packaging, aseptic processing and pharmaceutical microbiology, as well as biotechnological areas, such as sterile filtration, ultrafiltration, and chromatography.

For more than 70 years, PDA has been providing high-quality, expert manufacturing resources to meet the needs of our members and other industry professionals involved in these aspects of bio/pharmaceutical manufacturing. These resources include:

  • Peer-reviewed technical reports offering guidance on a variety of manufacturing-related topics, such as aseptic processing, validation of dry and moist heat sterilization, steam-in-place, validation of tangential flow filtration, sterilizing filtration, virus filtration, parametric release, validation of column-based chromatography, pharmaceutical package integrity, process simulation of aseptic processing, process validation, technology transfer, single-use systems, reprocessing, and identification and classification of nonconformities in glass vials and in elastomeric closures, to name a few.
  • Conferences and workshops focused specifically on trends in manufacturing, such as Quality Risk Management (QRM) for manufacturing systems, aging facilities, analytical methods, continuous manufacturing, glass quality and handling, single-use systems, lyophilization, pharmaceutical packaging, and prefilled syringes and injection devices.
  • Lecture and lab-based education courses providing in-depth training and practical solutions to manufacturing challenges, including aseptic processing, bioburden and biofilm management, cleaning and disinfection, container closure and integrity testing, contamination control and environmental monitoring, cleanroom and isolator technology, facility design and operation, filtration, GMPs, moist heat sterilization, single-use systems, technology transfer, visual inspection, and multiple courses on the validation of manufacturing processes.
  • Subject matter expert-generated content on the latest manufacturing science covered in the PDA Journal of Pharmaceutical Science and Technology and PDA Letter magazine.

Further, we monitor and support the global regulatory interests of our members. We have frequent interactions with global regulatory authorities related to GMPs. We do this by cosponsoring meetings with regulators (FDA, EMA,PIC/S, ICH, ANVISA), and through our commenting teams, who respond to health authorities with PDA’s official thoughts on proposed regulations and guidances. By doing this, we promote science-based regulations.

PDA recognizes that to better serve patients we must improve manufacturing processes and efficiencies and build quality into our products, rather than inspect after. We are committed to helping to advance technological enhancements by identifying improvement and facilitating dialogue with regulators to encourage adoption.

To that end, PDA has established a formal steering team to guide PDA’s future manufacturing efforts through the Manufacturing Science and Operations ProgramSM.

PDA’s Manufacturing Science and Operations Program (MSOPSM) — Enabling Pharmaceutical Manufacturing’s Future

In an effort to continue PDA’s leadership position at the forefront of advances in bio/pharmaceutical manufacturing, PDA has established the Manufacturing Science and Operations ProgramSM, the goal of which is to:

  • Highlight the ongoing focus PDA has on pharmaceutical and biopharmaceutical manufacturing
  • Strengthen and build practical solutions by filling known gaps in current manufacturing science as well as gaps that will become apparent based on ongoing developments and analyses
  • Identify and encourage use of new manufacturing technology and methods

The steering team has identified several areas of interest which we are beginning to explore, which include the following:

  • Leveraging Technology — Leveraging technology is about delivering existing technology faster and more efficiently, this will enable suppliers to provide one best solution even if it’s less expensive and deliver new technology faster
  • Manufacturing Organization, Culture and Process Understanding — Improving these three areas will lead to operational/technical improvements
  • Data on the Shop Floor — Using manufacturing data in real time on the shop floor will deliver better decisions and reduce variability
  • Aseptic Processing/Technology/Real-Time Release — Implementing technology advances in aseptic processing as well as real-time release will lead to improvements in pharmaceutical and biotech manufacturing as well as the quality of drug products and delivery devices

To learn more about how PDA is promoting progress in bio/pharmaceutical manufacturing, how you can benefit from the expert tools and resources available and how you can become involved in this initiative to advance bio/pharmaceutical manufacturing, please visit the PDA website.