Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen
The presence of foreign particles (sometimes also referred to as: visible particles, insoluble particles/matter) in APIs or Excipients represents a topic of increasing interest and concern of regulators and customers. Although to some extent technically unavoidable, this is caused by the fact, that analytical methods for the detection have been constantly improved but at the same time the guidance from Pharmacopoeias (e.g. EP, USP) or health authorities (e.g. EMA, FDA) about particles is very limited: certain drug products are expected to be “essentially free from visible particles” (USP <790>) or “practically free from particles” (Ph. Eur. 2.9.20.).