USP Proficiency Testing Program News (United States Pharmacopeia)
A few weeks ago, we announced that USP had entrusted CymitQuimica as the official distributor in Iberia for a new program aimed at quality control and R&D laboratories in the pharmaceutical sector seeking to be more competitive with their samples analyzed and compared by an external agent.
This is the Proficiency Testing Program (PTP), which, in accordance with ISO/IEC 17043:2010, helps participants take their QMS (Quality Management System) to the next level. That is how laboratories have an external view of how reliable their procedures are and will be in a much more favorable position in order to face laboratory and product certifications/regulations.
In this article we note some points that have emerged in recent weeks with some of you in order to clarify concepts about the Proficiency Testing Program:
Why should I join the USP Proficiency Testing Program?What is its utility?
Validates the commitment of the laboratory and the company to improve quality and reduce uncertainties in their procedures.
It favors the accreditation/certificationprocess of laboratories for different quality standards and product regulations.
Provides key information to evaluate methods and instrumentation
Provides training for lab’s personnel
What is “Proficiency Testing”?
It consists of the evaluation of the participant's process compared to pre-defined criteria through interlaboratory comparison (comparing results with other laboratories worldwide) as governed by the ISO/IEC 17043:2010 standard, clause 3.7. The Proficiency Testing proceeds through studies planned over time to evaluate the competence of the analysts (the quality control participant laboratories).
When are the studies planned?
In the description of the different PTP Kits on our website you will find the first studies scheduled for 2022 by USP-NSI. They are intervals, not specific dates, which gives laboratories flexibility to prepare the samples.
How does the program work?
The process goes as follows: the laboratory acquires the kits that are most convenient for them to qualify its procedures (see our Shop CymitQuimica USP Proficiency Testing Program), the instructions for each test are followed, and the results are sent through the USP portal to the institution where samples are analyzed and statistically compared to obtain results subject to USP quality standards without external bias.
Discover the range of PT Kits in Shop CymitQuimica USP Proficiency Testing Program. Some of the analysis for which there are PT kits are:
Chromatography HPLC-Liquid, Chromatography HPLC-Solid, Chromatography GC-FID, Titration-Potentiometric, Titration-Colorimetric, Conductivity, Residue on Ignition, Uniformity of Dosage Units, Potential Hydrogen-pH, Spectroscopy-uv/vis, Water Determination-Liquid, Water Determination–Solid, Loss on Drying, Refractive Index, Microbiological Examination, Residual Solvent-Solid, Residual-Liquid, Optical Rotation, Elemental Purities, Chromatography UPLC-Liquid, Sterility, Microbial Enumeration, Spectroscopy-FTIR and many more.
