Abstract
Visual inspection continues to be an important control method to ensure consistent product quality and patient safety. The desire to detect and remove low numbers of non-conforming units from production batches has resulted in the need to perform 100% visual inspection. The uncertainty of inspection results has been made more complicated by ambiguous compendial and regulatory expectations. It has been difficult to translate requirements to be “essentially free from visible particulates” or “free from readily detectable foreign matter” into quantitative terms that can be applied to batch acceptance and release. This is further complicated by incomplete descriptions of inspection conditions, without which the term visible has no meaning. A definition of reference inspection conditions, which include the critical parameters of light intensity, background and time are necessary to define what is visible under these conditions. This paper discusses the revision of reference inspection conditions in Section 6.06 of the Japanese Pharmacopeia (JP) and the development of new chapters 〈790〉 and 〈1790〉 in the United States Pharmacopeia (USP) to define both reference inspection conditions and acceptance criteria. Work by both organizations is helping to harmonize inspection methods and expectations as described herein in support of the global pharmaceutical industry and the patients it serves.
