In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter. In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present.
In 2014, recalls in injectable drugs spiked dramatically due to visible particles. The concerned seemed to begin when USP created chapter <1> titled “injections”—it was stated that each batch of drug products had to be “essentially free” of visible particles. Manufactures were unsure of what “essentially free” meant. It was never clear of what an “acceptable level” for particulate matter was.
In August of 2014, USP <790> became official. This was a positive development for drug manufactures and the FDA. This chapter gave guidance to manufactures with helping define “essentially free” of particulate matter.
Stephen Langille, Senior MicroBiology Consultant at ValSource, released a paper offering advice to manufacturers about when to recall a drug and when not to recall. He discusses how to tell an acceptable level of contamination within a specific drug product from a holistic point of view.
Stephen also created an elemental checklist for what drug product owners should ensure that is established for visual inspection based off of USP <790>. In this checklist, it reminds manufactures to establish size range of different visible particles, have operators qualified with regular eye exams, ensure inspection station is free of its own defects/ scratches, etc.
Biopharma companies should ask what specific inspection process they are following—for example, the European Pharmacopeia chapter 2.9.20 or USP chapter <790>. It is stated that all of these things should be investigated by any drug owner of their CDMO (Contract Development and Manufacturing Organization).
To learn more about Stephen Langille’s holistic view on defining “essentially free” of visible particulate matter and following USP <790>, click the link to read the full article.