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

Enverify™ Test Kits

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Inoculator

Instant Inoculator™

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endotoxin

Endotoxin Reference Standard

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What's New

<1120> Ensuring Microbiological Quality of Articles of Botanical Origin

Open for comment through Mar. 31, 2025: <1120> Ensuring Microbiological Quality of Articles of Botanical Origin

free sample offer

Free sample

Ending Apr. 30, 2025: Request Your Free Sample of Enverify™ or Instant Inoculator™

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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