CPTGlossary

Pharmaceutical Societies

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.

Agencies

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.

Our facilities will be closed on Monday, May 30th in observance of Memorial Day.

Due to the forecast calling for snow and out of an abundance of caution we will be having a delayed opening tomorrow. Our facilities will now be opening at 10 AM on January 7th, 2022.