Compendial microbiological testing is a critical component of pharmaceutical quality and regulatory compliance. This testing verifies that non-sterile drug products, raw materials and supporting components meet established microbiological quality standards recognized by both U.S. and international pharmacopeias.
At Perritt Laboratories, this service is performed in an FDA-registered, cGMP-compliant, and ISO 17025:2017 laboratory environment, providing clients with confidence that their data will stand up to regulatory review and global market expectations. If you’re seeking a laboratory that offers nonsterile microbial testing or other related services, we have the expertise to meet your needs.
As a specialized contract testing laboratory with decades of focused experience, Perritt Labs delivers compendial microbiological testing that supports product safety, safeguards compliance and helps reduce regulatory risk throughout the product life cycle. Our work is grounded in robust quality systems, deep regulatory knowledge and a consultative approach that prioritizes clarity, consistency and defensible results.
Compendial microbiological testing is designed to confirm that nonsterile pharmaceutical products meet defined microbiological acceptance criteria prior to release and throughout stability studies. These tests help manufacturers demonstrate control over bioburden, confirm the effectiveness of microbial limits and validate that products remain safe and suitable for patient use.
In aligning testing with recognized pharmacopeial standards, manufacturers can support submissions, inspections and ongoing compliance obligations with reduced risk. Perritt Laboratories works closely with clients to make sure testing programs are appropriate for the product, manufacturing process and intended markets while remaining aligned with current regulatory expectations.
In addition to routine compendial testing, Perritt Laboratories supports clients with method development and method suitability assessments when products present unique formulation or matrix challenges. Our microbiologists evaluate potential interferences, optimize recovery and ensure that test methods are appropriate, reproducible and defensible.
Every project includes detailed analysis and in-depth reporting designed to withstand regulatory scrutiny. Reports clearly document methodologies, results and observations, providing transparency and confidence for quality, regulatory and audit teams. This level of documentation supports smoother inspections and reinforces trust in the data behind each product release decision.
Perritt Laboratories provides a comprehensive range of compendial microbiology services tailored to nonsterile pharmaceutical products and related materials. Our core offerings include:
Our USP <61> and <62> testing services, along with our EP and JP offerings, are performed using validated methods aligned with GMP current standards. Our team remains actively engaged with evolving regulatory guidance to help clients stay ahead of changes without taking on that burden themselves.
Perritt Laboratories is known for its regulatory expertise, personalized service and long-standing reputation for reliability. Clients rely on our compendial microbial testing services to meet requirements, strengthen their overall quality strategy protect their brands from the consequences of noncompliance, and most importantly – patient safety.
Whether you are preparing for an FDA inspection, supporting a submission or maintaining routine quality control, our team acts as an extension of yours, offering guidance grounded in experience and a quality system built for consistency.
Compendial microbiological testing should never feel like a checkbox. When performed with precision, expertise and regulatory insight, it becomes a powerful safeguard for your product and your organization.
Contact us to discuss your testing needs and discover how our specialized microbiology services can help you move forward with clarity and confidence.
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