OTC Laboratory Product Testing Services

Certified Laboratories is an industry leader in Over-the-Counter (OTC) testing throughout the product lifecycle. We confirm active and inactive raw material, in-process and finished goods specifications of identity, purity, strength and quality using validated and verified testing methods and equipment.

Serving both OTC manufacturers and distributors, we are committed to helping you ensure your product’s quality. We can assess the of presence of microbial contamination, establish shelf-life, and inform product labeling.

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Micro Quality Labs, ABC Testing, and Microconsult are now Certified Laboratories. Same locations with expanded services and capabilities.

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Why Do Over-the-Counter (OTC) Testing with Certified Laboratories?

FDA requirements for OTC product testing is defined in OTC Monographs and in FDA’s current Good Manufacturing Practices (cGMP) regulations:

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21 CFR 210 for Manufacturing Processing, Packing, or Holding of Drugs

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21 CFR 211 for Finished Pharmaceuticals

Compliance with OTC Monographs and cGMPs help ensure product quality, efficacy, and reliability.

Certified Laboratories are experts in FDA Monograph and cGMP testing and regulatory requirements. Our full scope of laboratory capabilities includes chemistry, microbiology, toxicology, in-package stability and shelf-life, sterility, and quantitative components to inform product labeling for both APIs and excipients. We are an ISO accredited laboratory, helping you to ensure product quality with our state-of-the-art equipment and validated/verified methods.