{ENGLISH} CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 1

CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 1

 

1. No pharmaceutical product can start without water

The importance of water for the pharmaceutical products:

Water is one of the most important ingredients. The Water used to dissolve raw materials and water added during granulation are ultimately included in the final product. Large quantities of water and steam are also used in the cleaning (CIP) and sterilization (SIP) of Process equipment and containers that contact with products directly. Most of the comportment of injections are the water, which is called “water for injection (WFI)”. Thus, if the quality of Water for pharmaceutical use is poor, the water itself can enter the human body and cause adverse effects.

 

2. Production support facilities subject to GMP

While the main machinery used in the manufacturing process is called production equipment (or Process Equipment), utilities and HVAC for manufacturing are called “Production support facilities”.

Since Production support facilities are subject to GMP, water for pharmaceutical use must also be controlled under GMP.

In addition to production equipment and production support facilities, there are other facilities and areas in a manufacturing plant that are related to product quality, such as warehouses and laboratories.

Since these areas are subject to GMP, they should be clearly separated from non-subject areas such as the cafeteria and administrative building (offices).

 

3. Types of water for pharmaceutical use

Impurities in Water for pharmaceutical use can be taken into the human body through pharmaceutical products.

Therefore, impurities must be removed from Water for pharmaceutical use to a level that does not affect humans, and the Japanese…