The Initial Steps Toward Understanding GMP for Drugs: 2

1. Introduction

In my previous article, I wrote about the importance of seeing GMP as a system which ensures quality of drug products i.e. quality system and about ISO 9001, the basis of the quality system-based principle. In this article, I would like to write about the guideline titled "Pharmaceutical Quality System" (ICH Q10) which was developed based on ISO 9001. The guideline which covers all the processes of drugs i.e. R&D, manufacturing, and quality control, and facilitates continuous improvement.
In Japan, ICH Q10 was issued as a notification dated February 19, 2010. For your reference, ICH is an abbreviation of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, established tripartitely by Europe, Japan, and the US for the purpose of promoting harmonization as well as more efficient processes of R&D and authorization. As of today, a number of countries and agencies are part of the organization. ICH Q10 is the 10th guideline on quality. For GMP, it has Q7 titled "Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients". 
ICH Q10 was laid down because having GMP only for plants (manufacturing sites) was insufficient to ensure quality of drug products thus new aspects such as responsibilities of the company (management) and sharing technologies and knowledge between R&D and plants should be included.
Now, I would like to outline the guideline below.

2. Product Lifecycle

ICH Q10 covers the whole product lifecycle. A product lifecycle consists of the following 4 stages: 1) pharmaceutical development, 2) technology transfer, 3) commercial manufacturing, and 4) product discontinuation. The purposes of this guideline will be achieved by establishing and maintaining a quality system through all of these 4 stages, i.e. the whole product life cycle.
What are the purposes of ICH Q10 then? These are said to be: 1) to achieve product realization, 2) to establish and maintenance a state of control, and 3) to facilitate continual improvement. In other words, these are: to review the process of establishing  and maintaining the quality system in the past and present (2), to find out issues and revise the system based on them (3), and to ultimately ensure product quality through these efforts (1).

３．Management Responsibility

One of the biggest features of ICH Q10 is that not only the plant but management i.e. the company is required to take responsibility. Who is/are management? Management is/are the personnel in positions which allows them to control resources thus the president and manufacturing/quality assurance executives. At a plant, the plant manager can be seen as a member of the management team.
Management responsibilities are listed in ICH Q10. It describes, "Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system". This could be seen as the biggest responsibility. A company must establish its own quality system based on the quality policy and goals set by management.