Microbiological quality control testing

USP is addressing critical industry needs by helping ensure product safety with advanced microbiology solutions.

Creators of pharmaceutical products, including drug developers, manufacturers, and compounders, strive to accelerate patient access to the quality medicines they need. Tight timelines and resource constraints drive efforts to optimize operational efficiencies, including robust quality control strategies. Reliable microbiological quality control solutions are essential to help reduce contamination risk, support quality, and safeguard patient safety.

USP has been a trusted source of solutions to microbiology challenges for the pharmaceutical industry since establishing the first microbiological documentary standard in 1965, helping companies confidently navigate regulatory expectations for contamination control.

Building upon this long history, USP now offers tools to enhance microbial contamination control in manufacturing and compounding, based on innovative preservation technology.

These tools, combined with USP quality standards, can improve contamination control and sterility assurance, helping ensure drug safety and boosting manufacturers’ confidence in their ability to meet regulatory expectations.

testing surface

Product

Enverify™ Viable Surface Sampling Competency Kit

Instant Inoculator

Product

Instant Inoculator™ reference microorganisms

endotoxin

Reference Standard

Endotoxin Reference Standard.

Drug Products

Education

Microbiology Course Catalog

What's New

PDA letter

Article

Enhancing Consistency in Environmental Monitoring: Addressing Variability in Surface Sampling

Microbial Preservation Article

Interview Article

How Microbial Preservation Supports Quality and Safety in Compounding Pharmacies

white paper: Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

White Paper

Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

Stratix Labs press release

Press Release

USP Acquires Stratix Labs, Enhancing Its Microbiology Portfolio with Innovative Technology.

Stratix Labs FAQs

FAQs

USP Acquisition of Stratix Labs.

Resources


Articles and documents

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Education

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Documentary Standards

Note: Some links require a USP-NF Online account to access

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