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The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.
The European Pharmacopoeia Commission (Ph. Eur.) is seeking comments from manufacturers, regulatory agencies, and other stakeholders as the commission considers whether or not to update its monograph, Eye Preparations (1163), to include a specification for particulate contamination for eye drops and eye lotions that are solutions. The comment period is open until June 30, 2015.
According to the European Directorate for the Quality of Medicines & Healthcare (EDQM), “the current monograph does not set requirements/limits for sub-visible particles in eye preparations. In other regions of the world (e.g., United States and Japan), such requirements are considered very important for patient safety. Furthermore, sub-visible particles are a reflection of the quality of the manufacturing process and may indicate a risk of microbial contamination.”