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Strong-Cobb #221

Open timbrisc opened 2 years ago

timbrisc commented 2 years ago

Issue migrated from trac ticket # 5823

component: organization | priority: minor | keywords: Strong-Cobb

2022-06-07 20:51:25: william.hess@fda.hhs.gov created the issue

UCUM Board needs to provide input. A Strong-Cobb is an ad hoc unit of force which is a legacy of one of the first tablet hardness testing machines. Although the Strong-Cobb is arbitrary, it was recognized as the international standard from the 1950s to the 1980s. Strong-Cobb represented roughly 0.7 kilogram of force or about 7 newtons. Although the Strong-Cobb unit is arbitrarily based on the dial reading of a hardness tester, it became an international standard for tablet hardness in the 1950s until it was superseded by testers using SI units in the 1980s. The Strong-Cobb is a unit with a very unusual name for a unit of measurement since it is named after the company, Strong-Cobb Inc. The inventor of the hardness tester was Robert Albrecht, the plant engineer for the Strong-Cobb Company. He sold the patent to the company for $1.00. See https://en.wikipedia.org/wiki/Tablet_hardness_testing.

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."