USP Testing
Contaminated medicines, preparations and personal care products are potentially hazardous to patients. Millions of prescriptions, and non-sterile products are compounded each year and it is up to fabricators and packagers to ensure customers receive quality preparations that are free from contaminants. The United States Pharmacopoeia Convention (USP) outlines a series of regulatory guidelines that are integral in understanding the risks inherent in the compounding and manufacturing process.
USP standards are used by regulatory agencies to help maintain consistent quality in consumer products. It is important to ensure that every level of manufacturing from the raw materials down to finished products and even the manufacturing environment are all in compliance with quality assurance and quality control systems.
It is useful to assume that the operator is always contaminated while operating in the aseptic area. If the procedures are viewed from this perspective, those practices which are exposing the product to contamination are more easily identified.” Hank Avallone – 1988
It is useful to assume that the operator is always contaminated while operating in the aseptic area. If the procedures are viewed from this perspective, those practices which are exposing the product to contamination are more easily identified.” Hank Avallone – 1988
USP Tests
- USP 61 – Microbial examination of non-sterile products, microbial enumeration tests [USP61]
- USP 62 – Microbiological examination of non-sterile products, tests for specified microorganisms [USP62]
- USP 797 – Pharmaceutical compounding, sterile preparations [USP797]
Please contact us for more details regarding our USP testing services and pricing.
