pascal second

[timbrisc]

Issue migrated from trac ticket # 5813

component: organization | priority: minor | keywords: Pa·s

2022-06-07 20:06:21: william.hess@fda.hhs.gov created the issue

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UCUM already has "Pascal" so the UCUM Board should also consider adding "Pascal second". It is defined in wiki (https://www.aqua-calc.com/what-is/dynamic-viscosity/pascal-second) as "A unit of measurement of dynamic viscosity. A pascal-second (Pa·s) is a derived metric SI (System International) measurement unit of dynamic viscosity. Pa·s is equivalent to N × s ÷ m2 or kg/m/s. Consider a fluid placed between two parallel plates, and the top plate is pushed parallel to the bottom plate with constant pressure of one pascal. If the top plate moves a distance equal to the distance between the plates in one second, then the fluid between the plates has dynamic viscosity of one pascal-second."

This new concept is needed to support the U.S. Food and Drug Administration Pharmaceutical Quality Chemistry Manufacturing and Control (PQ/CMC) initiative. Please see https://www.regulations.gov/document/FDA-2022-N-0297-0001, which in part, states:

"PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, batch formula, and batch analysis, which are important aspects of drug development. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary.

The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. PQ/CMC standardization supports FDA's regulatory needs in receiving structured and standardized data in pharmaceutical quality and includes two objectives: (1) To standardize the pharmaceutical quality data that is currently received by FDA in eCTD Module 3 from the sponsoring organizations, and (2) to use these structured elements and develop a FHIR data exchange solution."

[dr-shorthair]

Pascal-second is already available in UCUM - Pa.s

[gschadow]

Agreed, close.