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Editor's Message

PDA Contaminates Podcast Scene

Contamination control is a major concern for readers of the PDA Letter. Recent news articles in the news uPDAte show this concern is valid. In July alone, the U.S. FDA cited a number of companies for inadequate contamination control. A nonsterile drug manufacturer was warned about ineffective cleaning processes to prevent cross-contamination (1). FDA told another manufacturer it failed to follow procedures for cleaning and disinfection (2). And a manufacturer in India was cited for, again, inadequate cleaning practices (with some data integrity violations thrown in as well) (3).

Naturally, articles and videos on prevention of contamination, particularly microbial control, are some of the most-read articles in the PDA Letter. PDA’s annual Global Conference on Pharmaceutical Microbiology remains one of our more popular meetings, having grown in significantly in little more than a decade.

For this reason, we want to continue providing our readers with the latest information on this important topic. As part of this effort, we are working on a new PDA Letter podcast that will focus on contamination events and other GMP stories from the industry. Since Serial hit the scene in 2014, podcasts have become a medium to be reckoned with. Shows cover everything from sports to true crime to news analysis. Considering that the Letter provides both written articles and videos, it made sense to also join the ever-growing ranks of podcasters. Our first episode will launch this fall, so stay tuned!

Also, if you plan to attend the 14th Annual PDA Global Conference on Pharmaceutical Microbiology in October (and I highly recommend you do so), feel free to stop me and let me know what you think of this and other Letter content!

Also, I want to thank our summer intern Madeline Cusick for coming up with the witty title for this Editor’s Message. She has now resumed her journalism studies at Georgetown University. An upcoming issue will feature Madeline’s summary of her summer at PDA.

References

  1. “Non-Sterile Drugmaker Hit for Inadequate Cleaning.” Drug Industry Daily (July 18, 2019).
  2. “Connecticut Manufacturer Gets FDA Warning Letter.” Pharmaceutical Technology (July 17, 2019).
  3. Palmer, E. “Indoco caught in maelstrom of FDA concerns as plant hit with warning letter.” FiercePharma (July 15, 2019).