Fidelity to Science &amp; Correct Scientific Vocabulary—Microbial Control Versus Contamination Control

Edward C. Tidswell; Radha Tirumalai; David Hussong

doi:10.5731/pdajpst.2018.009795

Abstract

More than at any other moment in our history, it is imperative that we maintain fidelity to sound science and ensure the correct use of the associated scientific vocabulary. This is especially the case with respect to pharmaceutical microbiology and its practice in ensuring adequate controls in the manufacture of safe and efficacious therapeutics. Here, the current state of challenges and headwinds to pharmaceutical microbiology and how these are intimately linked with fidelity to sound science and the correct use of the associated scientific vocabulary are described. This is illustrated through the specific example of a misuse of the term “microbial contamination” within regulatory guidance and the adverse consequences that all stakeholders (patients, prescribers, industry, regulators, standard setting bodies) will encounter.

LAY ABSTRACT: More than at any other moment in our history, it is imperative that we maintain a fidelity to sound science and ensure the correct use of the associated scientific vocabulary. This is especially the case with respect to pharmaceutical microbiology and its practice in ensuring adequate and effective controls in the manufacture of safe and efficacious therapeutics. Here, the current state of challenges and headwinds to pharmaceutical microbiology and how these are intimately linked with fidelity to sound science and the correct use of the associated scientific vocabulary are described. This is illustrated through the specific example of a misuse of the term “microbial contamination” within regulatory guidance and the adverse consequences that all stakeholders (patients, prescribers, industry, regulators, standard setting bodies) will encounter.

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