Today, USP <85> continues to serve as the gold standard for Bacterial Endotoxin Testing (BET), relying exclusively on Limulus…
A New Era for Endotoxin Testing: USP <86> Introduces Sustainable Recombinant Alternatives to LAL
Today, USP <85> continues to serve as the gold standard for Bacterial Endotoxin Testing (BET), relying exclusively on Limulus…
Jul, Thu, 2025
FDA Investigator’s Manual
We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
FDA Investigator’s Manual
We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
Jul, Thu, 2025
Lessons Learned in Interpreting and Operationalizing USP 795 and USP 797 Updated Requirements
When industry veterans gathered in Boston for the 2025 Compounding Pharmacy Compliance (CPC) Conference, all eyes were on one…
Lessons Learned in Interpreting and Operationalizing USP 795 and USP 797 Updated Requirements
When industry veterans gathered in Boston for the 2025 Compounding Pharmacy Compliance (CPC) Conference, all eyes were on one…
May, Tue, 2025
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
Apr, Mon, 2025
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Jul, Wed, 2024
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
Oct, Tue, 2023
Facility Design and Construction Requirements | USP 795 & 797 Revisions
It is important to note that there have been significant changes made to the regulations governing Nonsterile Preparations and…
Facility Design and Construction Requirements | USP 795 & 797 Revisions
It is important to note that there have been significant changes made to the regulations governing Nonsterile Preparations and…
Oct, Thu, 2023
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sep, Thu, 2023
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Jul, Tue, 2023
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…