It appears that talking about the quality of drugs/pharmaceuticals and their products has become a fashionable topic, in particular with respected scientists and regulators. There appears to be clear fearmongering and a blame-game approach that is taking place to discuss the subject and perhaps to gain personal or professional recognition along the way. Such human elements are natural or expected; however, when it comes to science then such emotional distractions should be managed, preferably set aside. This article is an attempt to provide a rationale and scientific point of view to highlight current difficulties in setting standards for developing and manufacturing quality drug-products, in particular tablet and capsule.
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