PDA Letter Article

Voices of the Board: PDA Technical Pubs

by Mary Oates, PhD

Mary OatesRecently, I was engaged in a lively debate with several others about microbial control requirements for manufacturing cell and gene therapy products. We could find no specific regulatory guidance on the topic so, of course, we turned to PDA for answers.


This caused me to think about the many times I have reflexively sought out PDA’s technical reports, points-to-consider documents, surveys and other invaluable resources to supplement what I already knew or to teach me what I needed to learn. I know I am not the only one.

PDA has been publishing technical reports for more than four decades. A review of these documents, beginning with Technical Monograph No. 1: Validation of Steam Sterilization Processes* in 1978, provides a glimpse into the history of manufacturing science and the critical role PDA has played in its evolution.

In the 1980s and 1990s, PDA volunteers crafted technical reports on foundational topics such as validation of sterilization processes and water systems, environmental monitoring programs, use of chromatography and tangential flow filtration for purification of biopharmaceuticals and aseptic process simulations.

At the turn of this century, PDA was enabling its constituency to adopt improved technologies and ways of working, including rapid micro methods, isolator systems and parametric release. Technical reports outlining practical approaches to quality risk management and lifecycle process validation followed. More recently, guidance has been provided on control strategies for cell-based therapies and implementation of pre-use/post-use sterilization integrity testing.

In addition to helping lay the foundation for manufacturing science, PDA volunteers have helped our stakeholders avoid numerous potential issues over the years. Technical reports and/or points-to-consider documents have been published on the detection and mitigation of odors due to tribromoanisole/trichloroanisole (which led to multiple product recalls in the early 2010s), prevention of drug shortages, data integrity management and best practices in glass vial handling and processing. PDA also played a key role in helping the industry navigate the many challenges that arose due to the COVID19 pandemic.

I am but one of the tens of thousands who have found the guidance they needed in PDA’s resources. I encourage you to join us. I also encourage you to volunteer. In doing so, you will help lay the foundation for the next forty years!

*Note: PDA Technical Report No. 1, Revised 2007: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, was revised in 2007 and was translated into Spanish in 2021.