Categories

  • 01 Regulation
  • 02 Quality System
  • 03 Production
  • 04 Lab.
  • 05 Facilities/Equipment
  • 06 Biological Technologies
  • 07 Medical Device
  • 08 Others

Regulation

Article list by Category
Regulation

In this category "commentary"and "trend" of the verious guidelines for medical field including regeneration medicine and medical device with the international GMPs such as PIC/S. In addition, the topics related to the regulatory application are also introduced.

Quality System

Article list by Category
Quality System

GMP is thought to be the science of quality assurance "not to produce, release or administer the pharmaceutical products with manufacturing defects. And pharmaceutical quality system(PQS)is a system to strengthen and complement the GMP. This category includes the article related to the operation of the GMP and the PQS.

Production Control

Article list by Category
Production Control

This category includes the themes related API, drug product, packaging and production. In addition, current technical information that will help in productivity and quality improvement of pharmaceutical manufacturing is introduced.

Lab. Control

Article list by Category
Lab. Control

In this category, the themes related to laboratory operations such as method validation are included. The information about analytical instrument is also provided.

Facilities/Equipment

Article list by Category
Facilities/Equipment

This category includes the themes such as engineering services related to the new construction or the expansion of factory facilities, maintenance of equipment and computerized system validation. The latest equipment information to help capital investment is also provided.

Biotech

Article list by Category
Biotech

The themes related to biotechnology including biopharmaceuticals such as antibodies and vaccines and regenerative medicine are provided in this category. In addition, state-of-the-art technology to help improvement of productivity or quality with bio-pharmaceuticals and regenerative medicines as well as the decision of capital investment are also introduced.

Medical Device

Article list by Category
Medical Device

In this category, the themes related to medical device such as QMS and QSR are included. The latest information is also provided to help development or production of the medical devices.

Others

Article list by Category
Others

Variety of the topics from pharmaceutical related topics such as patent/intellectual property or statistics to miscellaneous topics useful for any kind of business or pleasant for indivisual life. Surprising findings from this category might be helpful to business.

Service menu

GMP Platform provision of services