::Contents:: IPEC Japan Update. 1. Self-imposed Standards of Excipient GMP Self-imposed Standards of Excipient GMP 2014

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1 ::Contents:: IPEC Japan Update Keiji Kijima Ph.D. Feb. 6 th, 2015 Hotel Negresco Nice (France) 1. Self-Imposed Standards of Excipients GMP The Japanese Pharmaceutical Excipients Directory (JPED) is under revision 3. Japanese Pharmacopoeia Activity of GAB Self-imposed Standards of Excipient GMP 2006 of IPEC Japan has been revised from the viewpoint of coordinating with the Joint IPEC PQG GMP Guide 2006 and defined as Self-imposed Standards of Excipient GMP Revised Self-imposed Standards of Excipient GMP 2014 of IPEC Japan (Revised Excipient GMP 2014) is composed of Section 1 to 8 in the same manner as Joint IPEC PQG GMP Guide Regarding determination as to from which processing step GMP should be implemented, it is guided following the Joint IPEC PQG GMP Guide 2006 that judgment based on risk analysis and through knowledge of the process is required. This is considered to mean that suitable opinion of manufacturing site based on the real conditions and real intention of persons concerned can be reflected to implementation of GMP. This is also considered to be the real conditions globally. 1

2 Thus, the revised excipient GMP 2014 is considered to at the same time to stand comparison with the Joint IPEC-PQG GMP Guide 2006 and also to meet the requirements of the current excipient GMP Which has been formed based on the style peculiar to Japan. Explanation meeting on the Revised Excipient GMP 2014 was held on last December 12. After making partial revision, we are to make revision formally in an early date and then implementation will be made. 2. The Japanese Pharmaceutical Excipient Directory (JPED) is under Revision JPED has been edited by IPEC Japan. This book is widely known to persons concerned in the development of drug products in Japan and publication of revised edition has been desired earnestly recently. It has the following history: The first edition: published in1994 and its addendum in 1995 Revised edition: published in 2000, 2005 and edition is now under preparation. 2. The Japanese Pharmaceutical Excipient Directory (JPED) is under Revision The contents of JPED: Administration route, maximum dose amount and uses (wetting agent, lubricant, plasticizer, etc.) are introduced as information for reference considered useful for making drug marketing approval applications hereafter. Specification (JP, USP, EP. etc.), CAS No. Introduction of product (trade name, manufacturer, distributor) 3. Japanese Pharmacopoeia IPEC Japan is cooperating with the activities in the JP regarding harmonization, new admission and revision of excipient monographs. 2

3 The Progress of Revision of JP Sup.Ⅱto the Japanese Pharmacopoeia 16th Edition The Sup.Ⅱto JP 16th Edition was promulgated on February 28, According to custom in the revision of JP, the transition period is provided. In the case of drugs which are listed in the new Pharmacopoeia, they may be accepted as those being not listed in the new Pharmacopoeia before and on September 30, The Progress of Revision of JP Contents of revision: 1) Some revisions were made in regard to General Notices; General Rule for Crude Drugs; General Rule for Preparations; General Test, Processes and Apparatuses; and General Information. 2) Excipient substance newly added to the Official Monographs: Calcium Sodium Edetate Hydrate [based on the completion of harmonization and transferring to JP from Japanese Pharmaceutical Excipients (JPE)] 4. Activity of GAB a) Introduction of GAB Information for Excipient of Pharmaceutical Products among Pharmaceutical Companies under the Participation of GAB (GMP Auditing Board for Pharmaceutical Excipients) GAB is an independent organization established on April 1, 2005 as a third party in order to objectively evaluate the status of self-imposed standard of GMP for pharmaceutical excipients. 3

4 Introduction of GAB In conformity with the self-imposed pharmaceutical excipient GMP, GMP status at manufacturers of pharmaceutical excipients are evaluated. Based on the results, a certificate is issued. It is intended to ensure the quality of pharmaceutical excipients in Japan and to improve its reliability. b) Introduction of activities to share audit information of pharmaceutical companies A committee was created consisting of the major pharmaceutical companies (seven companies) and GAB to structure a system for sharing audit information for excipient as collaborative activities among pharmaceutical companies. c) Contents of the system suggested:: 1. For excipients manufacturers selected by the committee, audit is conducted and the information is shared among the committee member companies. 2. Audit to excipient manufacturers is delegated to GAB and standardization of the audit activities is achieved. d) Output expected:: Candidate excipient manufacturers to make audit are selected based on discussion in the committee. This allows to prevent duplication of audits. Thus it is expected that both excipient manufacturers and pharmaceutical companies will be greatly lightened of their expense and labor. 4

5 In order to develop the plan for the system, the GAB is making various workings like collecting of excipients manufacturer accepting the audit, making related agreement with pharmaceutical companies and excipient manufacturers, etc. The audit based on the system has been started as a pilot study recently. Thank you for your kind attention. Keiji Kijima Ph.D. IPEC Japan Feb. 6 th, 2015 Hotel Negresco, Nice France 5