Category: Regulatory Compliance & FDA Insights
-
USP 1231 Pharmaceutical water program changes
USP is being revised. Learn how proposed changes involving representative sampling, online TOC and conductivity, ozone, added substances, sterile packaged waters, and…
-
FDA 483 Microbiology Trends for 503B Facilities
Recent FDA inspection findings send a clear message to 503A compounding pharmacies and 503B outsourcing facilities: a passing sterility test is not…