USP: United States Pharmacopoeia: provides a framework on test methods, specifications and general information for pharmaceutical products.
BP: British Pharmacopoeia: provides a standard for UK pharmaceutical research.
EP: European Pharmacopoeia: provides a standard for European pharmaceutical research.
JP: Japanese Pharmacopoeia: provides a standard for Japanese pharmaceutical research.
EPA: Environmental Protection Agency
AAMI: Association for the Advancement of Medical Instrumentation
ANSI: American National Standards Institute
ISO: International Standards Organization
Tests and Practices
USP 71: sterility test typically used for pharmaceutical products or anything that can be injected into the body.
USP Purified Water: passes the USP monograph test for purified water.
Current Good Manufacturing Practices (cGMP): FDA’s regulations on the maintenance of manufacturing processes and facilities.
Master Batch Record: description of the pharmaceutical manufacturing process.
OTC Drug Monograph Process: evaluates the safety and effectiveness of OTC drug products marketed in the United States.
Cylinder-Plate Assay: a method of antibiotic potency testing that extracts the antibiotic active ingredient(s) from the product being tested using solvents and phosphate buffers as outlined in USP <81>.
Turbidimetric Assay: another method of antibiotic potency testing based upon the ability of the antibiotic being tested to kill a USP-specified microorganism that is present in solution, thereby reducing the turbidity of that solution.
Endotoxin Testing: an in-vitro assay used for the detection and quantitation of bacterial endotoxins in injectable products or implantable medical devices.
Low-Level Detection: the highly-sensitive type of testing that is utilized for analytes, which may be present in a material at a low-level.
1,4 Dioxane: a synthetic industrial chemical that, historically, has been used as a solvent in the synthesis of many types of industrial chemicals.