Author Archives: Tom Pritchett

FDA Inspection Trends for Cellular Therapies

According to the late Norman Cousins, “Wisdom consists of the anticipation of consequences.” When it comes to regulatory inspections, those consequences can be severe. However, the consequences of a problem anticipated can be prevented — given effective action to remediate the issue. In two previous articles (1, 2), I discussed the whys and hows of using the US Food and Drug Administration's (FDA's) notices of deficiency, FDA warning letters, and other information about inspection results to create an effective system…

Spotting, Tracking, and Predicting Inspection Trends

    Compliant companies, to paraphrase Tolstoy, are all alike. Every noncompliant company seems to find its own way to fall short of compliance with good manufacturing practice (GMP) and come, as did the writer’s famous heroine Anna Karenina, to grief. One commonality of compliant firms is that most seem to have excellent self-auditing/self-inspection programs. Indeed, many inspectors say that a primary predictor of a compliant company is a rigorous self-inspection program. Such a program is appropriately focused, adequately resourced,…

“Hard Cell”: Potency Testing for Cellular Therapy Products

Potency testing is defined in 21 CFR Part 600.3(s) as “the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result” (1). Potency measurement is especially important for complex products such as cellular therapies (CTs). It is considered an essential aspect of the quality-control system for a CT drug substance and drug product. It is…

A 483 Primer

The words of George Santayana — “Those who do not remember the past are condemned to repeat it” — ring especially true for companies regulated under good manufacturing practices (GMPs). Learning from and reacting to lessons from past inspections (both your own and those of other companies) is one of the best ways to prepare for future inspections. Regular review and close study of 483 notices issued during inspections can be an efficient and accessible means of identifying and absorbing…