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Draft guideline was issued and comments must be submitted to FDA by 6/22/2026. Let us know if anyone is interested to provide comments. Establishing Impurity Specifications for Antibiotics | FDA ------------------------------ Kim Huynh-Ba, MS, PMP, FAAPS Pharmalytik LLC, Managing Director Temple ...

Federal Register :: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments

Call for Volunteers – Leadership Opportunities We are seeking motivated members to join our leadership team and help shape the direction and impact of our community. These roles offer a unique opportunity to expand your network, develop leadership skills, and contribute to meaningful initiatives. ...

Welcome Message We are honored to serve as Chair and Vice Chair of this Pharmaceutical Quality Community (PQC) and are excited to build a dynamic, supportive, and forward-looking network together. Our mission goes beyond compliance-we are here to elevate one another. By ensuring drug products meet ...

We have several activities to build for the community, therefore, we have a drive for new leadership members. If you are interested in this topic, come and join us in our next telecon. Date:  Tuesday, April 20, 2021 Time:  4pm EST (1pm PST)  --------------------------------------------------------------------- ...

A special event to cover vaccine development from the first step to the last mile with participation from NIH, BARDA, HEALTH CANADA, SANOFI, JNJ, ASTRA ZENECA, AMGEN, and many more speakers.