Topics The 22nd Pharmaceutical Quality Forum Symposium" was held

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On February 26, 2020, the 22nd Pharmaceutical Quality Forum Symposium was held at the All Dentsu Labor Hall (Chiyoda-ku, Tokyo). The symposium was held in the midst of the social impact of the new coronavirus infection, and about 60 participants from various fields in industry, academia, and government attended the symposium, where lectures and active discussions were held under the title of "Current Status of ICH-Q Series".

Scene at the venue

Explanation of the purpose of the symposium (opening remarks)

History and explanation of ICH Q11

Kenji Ozaki of Shionogi Pharma explained how the topic was adopted, saying that a new quality assurance system based on science and risk management had been established for drug products, but not for APIs, which required much effort on the part of both companies and regulators. He explained that, unlike the manufacturing process for drug substances, it is more important to know about impurities and how to control them, and that the control strategies include "traditional methods" that focus on quality assessment through final testing, and "more advanced methods" that use meaningful and effective parameter management based on an understanding of the process and product, or a combination of the two, He explained that it is also possible to employ a combination of both. In selecting starting materials, it is important to consider all of the general principles rather than strictly applying individual general principles described in the guidelines, and since issues remained at the implementation stage with only the main body of the guidelines, a Q&A was prepared to more clearly demonstrate the appropriateness of the selection. Therefore, he added that a decision tree to facilitate understanding was attached to the guidelines, as well as Q&A to further clarify the appropriateness of the selection. He concluded by saying that in the future, appropriate communication in API applications between the company/regulatory side can be expected.

ICH Q Guidelines and Harmonization of Pharmaceutical Quality (focusing on chemically synthesized drugs)

Haruhiro Okuda of the National Institute for Health Sciences (NIHS) stated that the International Conference on Harmonization of Pharmaceutical Regulations (ICH), established in 1990, was incorporated 25 years later and that its mission has also changed from providing safe and effective new drugs more quickly to making new drugs available to patients in a timely and continuous manner. Looking over the quality-related guidelines that have been discussed so far, he noted that guidelines for stability, analytical methods, and impurities specified for approval applications and shipping decisions were developed around Q6 (specifications and test methods), followed by the issuance of the Q Quartet, which covers quality assurance from development to post-marketing, and that this concept has been taken over to facilitate lifecycle management. He explained that the control strategy is an important item in the Q Quartet, and that by implementing control in the upstream process using the Quality by Design*3 method, it is possible to control without relying on tests on the final product, and that it is also possible to build a good control strategy. He also explained that a robust process can be created by skillfully constructing a control strategy. Finally, he explained the growth of the pharmaceutical supply chain and regulatory convergence (Regulatory Convergence) in relation to the vision of ICH activities.

Current status and future prospects of ICH Q12

Mr. Tomonori Nakagawa of Otsuka Pharmaceutical Co., Ltd. stated that this topic was adopted because the Q Quartet had established a science- and risk-based operational and evaluation approach from drug development to approval, but had not yet achieved flexibility with respect to post-approval changes, nor harmonized the required regulatory procedures. The new term "Establishment" was adopted. He explained that the new term "Establish Condition*4" is legally binding information necessary to assure product quality and should be identified in the overall control strategy, including the sequence of each operation, rather than in individual unit operations in the manufacturing process. The analytical method also determined the definition of this information. The Post-Approval Change Management Implementation Plan*5 is to agree on a plan for changes prior to data acquisition, which will shorten the post-application review period; the Product Lifecycle Management*6 document is a summary of information on the Establish Condition and related change categories, transition . He stated that these guidelines will increase transparency on the part of companies and regulators regarding the management of post-approval changes, and will promote innovation and continuous improvement.

ICH Q13 activity status and continuous production efforts in Japan

Yasuhiro Matsui, Dainippon Sumitomo Pharma Co., Ltd. stated that this topic was adopted to ensure that the lack of international common understanding does not hinder the widespread use of the continuous production method, which is increasingly being applied to pharmaceutical products in many countries around the world. He stated that the scope of this topic is not a single process, such as tableting, but continuous production that integrates multiple processes. Next, he explained the status of the AMED (Japan Agency for Medical Research and Development) research efforts by industry, academia, and government in Japan, as follows. As a management strategy for continuous production, it is important to achieve a controlled state (State of Control) by measuring the quality of products, intermediate products, etc. in real time and adjusting process parameters from time to time according to fluctuations that occur during operation to achieve the desired quality. In addition, he introduced the items to be considered in process validation in continuous production and the definition of lot, and concluded by saying that the information in this topic is expected to promote continuous production. He concluded the presentation by saying that the information in this topic is expected to promote the use of continuous production.

Current status of ICH Q2 (R2)/Q14 and expectations from the industry and regulatory side

Hiroko Shibata of NIHS stated that Q2 (R2) (Revision of Analytical Method Validation) presents the concept of validation of spectroscopic analytical methods that require multivariate analysis, such as near infrared spectroscopy (NIR) in addition to liquid chromatography, and Q14 (Development of Analytical Methods) incorporates the concept of the Guidelines for Drug Formulation Development Q2 (R2) facilitates planning of validation for analytical methods that are not covered by the current guidelines (on the company side) and promotes common recognition and mutual understanding of analytical performance parameters and their evaluation methods. Q14 is expected to reduce the number of problems caused by analytical methods themselves (on the company side) and promote mutual understanding and knowledge sharing between the company and the regulatory side, leading to more flexible and efficient regulatory procedures and shorter regulatory approval process times. The guidelines are also expected to promote mutual understanding and knowledge sharing between companies and regulators, resulting in more flexible and efficient regulatory procedures and optimized resources (on the regulatory side).

Finally, these guidelines are expected to lead to more efficient drug development and more streamlined approval and post-approval change management.

Summary

In closing, Dr. Haruhiro Okuda of the National Institute of Health Sciences (NIHSS), referring to today's theme, said that guidelines are like a road, a piece of social infrastructure. In ICH, the existence of guidelines would facilitate corporate activities toward the intended goal, but even if only roads are built, they will not work without driver education and traffic laws and regulations. He also stated that even if roads are built, we should not assume a form of automated driving, but always aim for the latest and greatest and challenge it, and that is the kind of road we should be aiming for. He concluded the symposium by saying that it is the duty of all of us in the industry, academia, and government who will be involved in this field in the future to create good guidelines and to advance the industry through the creative and ingenious activities of companies within those guidelines.

( Tsutomu Konno, Production & Quality Control Dept.)

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