CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – END   9. Facilities for supplying water for pharmaceutical water There are many use points for “purified water” and “water for injection” in a factory, and the amount used varies from…

CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 3   8. Facilities for manufacturing pharmaceutical water A pharmaceutical water production facility is a series of devices (total system) to remove impurities from raw water to a level that…

CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 2   5. Overseas standards for pharmaceutical water The types and uses of pharmaceutical water have been described based on the JP (Japanese Pharmacopoeia), but this is a domestic standard,…

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…

  CHAPTER 4S2 RISK BASED C&Q – END   7. DQ Record DQ record consists of a checklist and reference documents, including reference specifications and reference drawings. DQ checklist and record format include the following: Test item Description…

CHAPTER 4S2 RISK BASED C&Q – PART 2   5. Lean Qualification Approach – Description for Each Document a. SVMP (Site Validation Master Plan) (1) Describe the outline flow of the project.