IPEC Japan Update Keiji Kijima Ph.D.

Feb. 6th, 2015

Hotel Negresco – Nice (France)

::Contents::

1. Self-Imposed Standards of Excipients GMP 2014

2. The Japanese Pharmaceutical Excipients Directory (JPED) is under revision

3. Japanese Pharmacopoeia

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4. Activity of GAB

1. Self-imposed Standards of Excipient GMP 2014

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 2014.

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 2006.

1. Self-imposed Standards of Excipient GMP 2014

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. Self-imposed Standards of Excipient GMP 2014

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 2007

2015 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 .

The Progress of Revision of JP

Sup.Ⅱto the Japanese Pharmacopoeia 16th Edition

The Sup.Ⅱto JP 16th Edition was promulgated on February 28, 2014. 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, 2015.

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)]

Information for Excipient of Pharmaceutical

Products among Pharmaceutical Companies

under the Participation of GAB (GMP

Auditing Board for Pharmaceutical

Excipients)

4. Activity of GAB

a) Introduction of GAB

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.

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.

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.

Keiji Kijima Ph.D. IPEC Japan Feb. 6th, 2015 Hotel Negresco, Nice France

Thank you for your kind attention.