GMP/Validation

GMP Design

Good Manufacturing Practice (GMP) is a set of regulations that defines standards for manufacturing control and quality control of pharmaceuticals and must be followed when manufacturing pharmaceuticals. It was implemented in Japan in 1979 and revised in 1996 to be included in the industry required authorization. We design equipment that is in compliance with the various GMP regulations. (GMP checklists and various technical checklists have been created and can be prepared.)

-Compatible with various GMP regulations

1	JGMP (GMP software and hardware/GMP notification)
2	CGMP (including FDA inspection guide/FDA guidance)
3	WHO GMP
4	EU GMP
5	ICH pharmaceutical GMP guidelines
6	FDA 21CFR Part 11
Designed to ensure efficient cleaning and maintenance so as to minimize the danger of faulty operation and prevent any negative effects to the quality of products through cross contamination, accumulation of dust or other conditions.

Validation

"Validation" is the validation of each step of the equipment design, manufacture and test run processes after GMP design has been completed. Validation standards were established and implemented in 1996 separate from pharmaceutical GMP.

Our GMP experts can assist you with the validation (validation and documentation of processes from design to manufacture and test run^*) based on prepared in-house validation standards.

* DQ, IQ, OQ, calibration, cleaning validation, computer validation

Equipment Validation Process

Implementation Examples

Pharmaceutical reaction chamber equipment

Summary	Delivered to a pharmaceutical manufacturing plant. Secondary ingredients are added to the main ingredients and these are stirred, heated and pressurized to create a chemical reaction.
Validation	DQ, IQ, OQ

Pharmaceutical reaction chamber equipment

DQ/IQ implementation plan and report

Pharmaceutical purified water manufacturing equipment

Summary	Purified water from the ion exchange resin tower is received using an 8 m³ D.I. water tank and travels through the water supply pipes, ultraviolet sterilizer and heat exchanger before it sent to each point of use via the D.I. water supply pump.
Validation	DQ, IQ, OQ, cleaning validation, calibration

Pharmaceutical purified water manufacturing equipment