GMP導入企業を支援します　GMP Support Center

General incorporated association

Japan GMP Support Center

 

GMP (Good Manufacturing Practices) is an international standard for manufacturing and quality control of pharmaceutical products. The World Health Organization (WHO) agreed to the enactment of the GMP in 1968. It was recommended to all countries in 1969. By law in Japan, it is known as "The Ordinance on Standards of the Production Management and Quality Control of Pharmaceuticals and Quasi-drugs." With the aim to improve public assurance of the quality of drugs, hardware (equipment) for each manufacturing plant of pharmaceuticals and software (manufacturing and rules) have been formulated. Therefore, in order to document the management of drug production according to the guidelines of the GMP, it is vital to enlighten people as to the production standards necessary to improve the production of pharmaceutical products. Today, food, drugs, and cosmetics are commercially available on a global scale.  Government authorities around the world now finely check the quality of products to ensure safety and provide peace of mind for the consumer.  In order to ensure quality control beyond each country’s standard due to ICH GMP, cGMP, and GMP guidelines of PIC/S.

As such, financial and logistical requirement would be a hurdle to have a uniform standard which encompasses all pharmaceutical manufacturing. In order to provide a uniform quality control and relieve the financial obligation to individual companies, Japan GMP support center provides consultation of the foundation necessary to bring your company into GMP compliance and to remain responsible with a system which provides appropriate documentation and necessary examination. In addition, we assure quality improvement through audits by providing operational advice.

 

GMP

GMP is made up of the following three elements. (1) The prevention of human error (2) prevent pollution and quality degradation (change or deterioration) (3) construction of the system to ensure a high level of quality control in each manufacturing process.

These 3 elements are supported by both the hardware and software elements which are built according to the standards of the GMP.  In addition, all actions are documented with respect to the assurance and the improvement of the quality of products. Continuous improvement is required to ensure quality and to meet the needs of society.  By the spirit of the GMP an attitude of excellence must be adopted. As always, the PDCA cycle is to strive to improve.

 

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Our business mission

·    Trustee of the audit work of GMP inspection and GMP authentication mechanism

·    Dispatch of lecturer of GMP to the education and training

·    Creating business of each SOP of GMP

·    Advice of hardware design of GMP introduction

·    Pharmaceuticals, exchange collaboration with various organizations related　to food and health food, etc.

·    Other businesses needed to achieve improved quality of people's lives

 

Support contents

Conduct the training, etc. of research and safety evaluation of experts based on scientific evidence, based on the GMP norms, it is less of what you do to build support and inspection of the GMP system of their respective companies.

· GMP audit of health food / raw materials manufacturing plant

And pharmaceutical / raw materials manufacturing subcontractors of trustees of GMP implementation status inspection

· SOP created in accordance with the production of health food and raw materials and education and training

· Trial relating to the manufacture of a medicament for the raw materials and investigational drugs SOP creation and education and training

And the United States support of expansion of health food / raw materials manufacturing plant to plan the US to FDA cGMP corresponding

And trustee of regular audit

· Of Pharmaceuticals / raw materials manufacturing plant to plan

for overseas PIC/S GMP support to the corresponding

And pharmaceuticals, educational activities to food and health food, etc. related to consumer protection in and Health Promotion

 

Note 1: US FDA cGMP (cGMP of dietary supplements by the US FDA)

Note 2: PIC/S GMP (pharmaceutical inspection agreement and pharmaceutical inspection cooperation scheme)

 

 

Contact details

 

General incorporated association

Japan GMP Support Center

Suzuka University of Medical Science

1001-1, kishioka-cho, Suzuka, 510-0293 Mie,

JAPAN

 

TEL/FAX : +81-59-384-9200

http://www.gmp-sc.or.jp  E-mail: info@gmp-sc.or.jp