One year have passed since the Japanese GMP regulatory authorities has become a member of PIC/S participating authorities on July 1, 2014. As we explained in various opportunities, accession to PIC/S is not a goal but a start of new situation, and now such situation is actually going on. The most significant event under such situation is on-going revision of PIC/S GMP guidelines. In addition, we have started active involvement to the various activities of PIC/S including participation in one of the 7 subcommittees sharing some area of PIC/S activities, and involvement in activities of Expert Circles organized to discuss and exchange information on specific technical area of GMP, develop draft guidance and to provide training (a framework among the inspectorates with a focus on training). Other routine activities such as exchange of inspection information or rapid alert with other PIC/S member authorities have already implemented. Since most of those activities and tasks require timely responses, good cooperation inside the regulatory authorities and communication with related industry become more important.
This publication has been prepared to express a sound and practical view on the better manufacturing environmental control for non-sterile pharmaceutical dosage forms, which has been discussed for several years by a special working group members of Kansai Study Group (KSG) accredited as one of the committees in Parenteral Drug Association (PDA) Japan Chapter. The opinions proposed or advanced in the document are formed for the purpose of furnishing a beneficial and valuable guide with advisability to any persons or organizations concerned in establishing appropriate manufacturing control systems for quality products. The leading topics discussed among the WG are focused on the prevention against cross-contamination and foreign matter ingress, and categorized into five subjects composed of HVAC systems, premises, gowning, cleaning, and cleanliness standards. Constructive and earnest discussion therein has been devoted to the key processes, wherein considerable amounts of powders are handled for the successful operations of weighing, granulation, mixing, and tableting. In the expectation of good usage, many of the principles and the way of thinking presented hereupon, in particular can be applied or rearranged to a wide spectrum of other manufacturing processes for various dosage forms of non-sterile drug products.
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.