I7163001 Introduction to GMP

Hiroshima University Syllabus

Japanese

Academic Year 2026Year School/Graduate School School of Pharmaceutical Sciences Program of Pharmaceutical Sciences

Lecture Code I7163001 Subject Classification Specialized Education

Subject Name GMP概論

Subject Name
（Katakana） GMPガイロン

Subject Name in
English Introduction to GMP

Instructor To be announced.

Instructor
(Katakana) タントウキョウインミテイ

Campus Kasumi Semester/Term 3rd-Year, First Semester, Intensive

Days, Periods, and Classrooms (Int) Inte

Lesson Style Lecture/Seminar Lesson Style
(More Details) Face-to-face, Online (simultaneous interactive)

Credits 1.0 Class Hours/Week 　 Language of Instruction J : Japanese

Course Level 2 : Undergraduate Low-Intermediate

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 03 : Pharmaceutical Sciences

Eligible Students Third-year undergraduates of Pharmaceutical Sciences and Medicinal Sciences, Six-year undergraduates of Pharmaceutical Sciences, Graduate students

Keywords GMP Pharmaceuticals, Manufacturing, Quality Management, Quality Assurance, Environment, Organization, Applications, Stable Supply, Sustainability
Learning steps: Third-step

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students) ・Acquiring foundational knowledge of the entire process from early-stage drug development through investigational drug manufacturing to commercialization (under GMP control) (Raw material procurement, auditing, formulation, packaging, quality testing, quality assurance, shipping) (Legal requirements, staffing, qualified personnel)
・Basic knowledge for dispensing practice (Dosage forms, packaging formats)
Criterion referenced
Evaluation
(Applicable only to targeted subjects for undergraduate students)

Class Objectives
/Class Outline Objectives:
・Acquire fundamental knowledge regarding the Pharmaceutical Affairs Law (PLA) and the assurance of efficacy and safety.
・Acquire knowledge of the GMP Ordinance (Good Manufacturing Practice, standards for manufacturing control and quality management), essential for pharmaceutical manufacturing.
・Expand career opportunities by learning the above foundational knowledge alongside the general organization and roles of pharmaceutical manufacturers and distributors.

Overview:
・Learn how pharmaceuticals are manufactured using specific equipment, how quality is ensured, and how they are supplied safely and securely.
・Understand the role pharmaceuticals play in improving quality of life, their social necessity, and the responsibilities involved.

Class Schedule lesson1
・What is GMP? ― GMP history and rules for safeguarding quality
・Legal background of GMP ― Pharmaceutical Affairs Law, PIC/S, MHLW guidelines
・Japan's current status within international regulations
・Exercises and practical training
lesson2
・GMP in Pharmaceutical Manufacturing Sites ― Clean Areas, Records, Training, Deviation and Change Management
・Roles of Quality and Manufacturing Departments
・Exercises and Hands-on Training
lesson3
・Management Required by GMP — Hardware and Software Management Methods for Quality Assurance
・Pharmaceutical Manufacturing and Sales Companies, Corporate Structure
・Exercises and Practical Training
lesson4
lesson5
lesson6
lesson7
lesson8
lesson9
lesson10
lesson11
lesson12
lesson13
lesson14
lesson15

Text/Reference
Books,etc. Handouts will be distributed.

PC or AV used in
Class,etc. Handouts, Microsoft Forms, moodle

(More Details)

Learning techniques to be incorporated Discussions, Project Learning

Suggestions on
Preparation and
Review Learn about GMP through lectures and exercises.

Requirements

Grading Method Assessment will be based on your attitude toward lectures and seminars, as well as your reports.

Practical Experience

Summary of Practical Experience and Class Contents based on it

Message

Other The number of Learning objects: B-4-1～4、D-1-3、D-3-1、D-5-1～2

Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching.

Academic Year	2026Year	School/Graduate School	School of Pharmaceutical Sciences Program of Pharmaceutical Sciences
Lecture Code	I7163001	Subject Classification	Specialized Education
Subject Name	GMP概論
Subject Name （Katakana）	GMPガイロン
Subject Name in English	Introduction to GMP
Instructor	To be announced.
Instructor (Katakana)	タントウキョウインミテイ
Campus	Kasumi	Semester/Term	3rd-Year, First Semester, Intensive
Days, Periods, and Classrooms	(Int) Inte
Lesson Style	Lecture/Seminar	Lesson Style (More Details)	Face-to-face, Online (simultaneous interactive)

Credits	1.0	Class Hours/Week		Language of Instruction	J : Japanese
Course Level	2 : Undergraduate Low-Intermediate
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	03 : Pharmaceutical Sciences
Eligible Students	Third-year undergraduates of Pharmaceutical Sciences and Medicinal Sciences, Six-year undergraduates of Pharmaceutical Sciences, Graduate students
Keywords	GMP Pharmaceuticals, Manufacturing, Quality Management, Quality Assurance, Environment, Organization, Applications, Stable Supply, Sustainability Learning steps: Third-step
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)	・Acquiring foundational knowledge of the entire process from early-stage drug development through investigational drug manufacturing to commercialization (under GMP control) (Raw material procurement, auditing, formulation, packaging, quality testing, quality assurance, shipping) (Legal requirements, staffing, qualified personnel) ・Basic knowledge for dispensing practice (Dosage forms, packaging formats)
Criterion referenced Evaluation (Applicable only to targeted subjects for undergraduate students)
Class Objectives /Class Outline	Objectives: ・Acquire fundamental knowledge regarding the Pharmaceutical Affairs Law (PLA) and the assurance of efficacy and safety. ・Acquire knowledge of the GMP Ordinance (Good Manufacturing Practice, standards for manufacturing control and quality management), essential for pharmaceutical manufacturing. ・Expand career opportunities by learning the above foundational knowledge alongside the general organization and roles of pharmaceutical manufacturers and distributors. Overview: ・Learn how pharmaceuticals are manufactured using specific equipment, how quality is ensured, and how they are supplied safely and securely. ・Understand the role pharmaceuticals play in improving quality of life, their social necessity, and the responsibilities involved.
Class Schedule	lesson1 ・What is GMP? ― GMP history and rules for safeguarding quality ・Legal background of GMP ― Pharmaceutical Affairs Law, PIC/S, MHLW guidelines ・Japan's current status within international regulations ・Exercises and practical training lesson2 ・GMP in Pharmaceutical Manufacturing Sites ― Clean Areas, Records, Training, Deviation and Change Management ・Roles of Quality and Manufacturing Departments ・Exercises and Hands-on Training lesson3 ・Management Required by GMP — Hardware and Software Management Methods for Quality Assurance ・Pharmaceutical Manufacturing and Sales Companies, Corporate Structure ・Exercises and Practical Training lesson4 lesson5 lesson6 lesson7 lesson8 lesson9 lesson10 lesson11 lesson12 lesson13 lesson14 lesson15
Text/Reference Books,etc.	Handouts will be distributed.
PC or AV used in Class,etc.	Handouts, Microsoft Forms, moodle
(More Details)
Learning techniques to be incorporated	Discussions, Project Learning
Suggestions on Preparation and Review	Learn about GMP through lectures and exercises.
Requirements
Grading Method	Assessment will be based on your attitude toward lectures and seminars, as well as your reports.
Practical Experience
Summary of Practical Experience and Class Contents based on it
Message
Other	The number of Learning objects: B-4-1～4、D-1-3、D-3-1、D-5-1～2
Please fill in the class improvement questionnaire which is carried out on all classes. Instructors will reflect on your feedback and utilize the information for improving their teaching.

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