From R&D and process validation to manufacturing and quality control—pharmaceutical companies are well versed in the important role of microbiological testing throughout the product development process.
A robust quality control program is essential for ensuring product quality and safety and ultimately protects the investments and long-term credibility of pharmaceutical companies. Further, quality control testing ensures that pharmaceuticals meet the standards specified under public health regulations. The United States Pharmacopeia (USP), for example, has developed quality standards to support the production of safe products. Likewise, the U.S. Food and Drug Administration (FDA) requires routine testing of pharmaceuticals to confirm the safety and efficacy of drugs before they reach the marketplace.
To ensure the accuracy of microbiological quality control tests, it is essential to use authenticated reference materials as controls. That’s why the pharmaceutical industry looks to ATCC to provide the top-quality strains necessary to maintain the highest levels of product integrity and reputation. By using ATCC products, testing labs can rely on quality systems, strain authentication, and meticulous microbial maintenance protocols. ATCC employs both traditional biochemical testing methods and automated phenotypic and genotypic analyses. This provides highly accurate identification across a wide array of microorganisms and can help avoid the pitfalls of misidentification, painful recalls, and regulatory repercussions.
Don’t take chances on the quality of your products—insist on authenticated reference strains from ATCC and make quality control an essential part of your pharmaceutical manufacturing process. Explore our portfolio of reference materials that support the microbiological quality control of pharmaceutical products.
Enhanced Pharmaceutical Sterility Testing Using ATCC Certified Reference Materials
Contamination of medicinal products by objectionable microorganisms is a major concern within the pharmaceutical industry, with potential effects on patient morbidity and mortality as well as product integrity and stability. The FDA regulates licensed pharmaceutical manufacturing companies to protect consumers and to enforce compliance with rigorous testing protocols. These regulatory standards include quality control methods—such as microbiological testing protocols described in the USP monographs—and the addition of antimicrobial preservatives. When properly followed, these processes prevent the distribution of products contaminated with objectionable microorganisms.Read the application note
Ensure pharmaceutical integrity
To help ensure the safety of your cell-based pharmaceuticals, ATCC offers mycoplasma detection services as well as a wide range of products that support the development and evaluation of novel mycoplasma detection methods. Don’t let mycoplasma contamination damage the quality or safety of your products.Get more info
Certified Reference Materials
Your scientific research requires biological products of the highest level of quality assurance, accuracy, and traceability. However, the inherent variability of biological materials brings unique challenges to establishing standards for in vitro model systems and setting up the ISO-compliant processes to produce them. Learn how our certified reference materials offer the reliability you need for incredible research results.Learn More