Does your company use cloth wipes on equipment in aseptic manufacturing areas? Do you launder and reuse them? Can you document that the use of the wipes is not creating particulates?
At the International GMP Conference held virtually in March 2022 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit shared agency concerns found during an inspection of a sterile drug manufacturer regarding cloth wipes.
- An FDA investigator’s perspective on cloth wipes
- A finding from an inspection of an ISO 5 area
- Data on cleaning-related 483 observations involving wipes
About the Expert
Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He writes the Redica Systems column “Conference Spotlight” and is working with our data engineers to build machine learning models for analysis of agency enforcement documents. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.
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