Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

TLDR

The increasing number and quantity of reference standards required for drug quality control are placing significant pressure on calibration and usage companies. This manuscript reviews the evolution of reference standards, proposes a digital reference standard, and discusses its necessity for holistic quality control in the internet‑plus era. The authors describe the four generations of reference standards and detail ten key characteristics of the digital reference standard, including digitalization, multidimensionality, big data, cloud computing, IoT, sharing, multi‑terminal access, intelligence, and compliance certification. The study summarizes the advantages and disadvantages of each generation and outlines the definition, benefits, and technical architecture of the digital reference standard.

Abstract

Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development of RS including physical RS, paper atlas, substitute RS and electronic databases. The advantages and disadvantages of each generation were summarized. The concept of digital RS (DRS) was proposed based on this, and summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.