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{ENGLISH} CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 2

CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 2 6. Establish appropriate cleanliness levels Pharmaceutical products should be manufactured in an environment with an appropriate level of cleanliness depending on the nature of the process.

{ENGLISH} CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 1

CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 1 How can you manufacture safe and effective pharmaceuticals? 1. Fortress to protect quality Three principles of GMP consist of (1) Minimize…

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

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…

{ENGLISH} CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 3

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…

{ENGLISH} CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 2

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,…

{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…

{ENGLISH} CHAPTER 4S2 RISK BASED C&Q – END

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…

{ENGLISH} CHAPTER 4S2 RISK BASED C&Q – PART 2

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.

{ENGLISH} CHAPTER 4S2 RISK BASED C&Q – PART 1

CHAPTER 4S2 RISK BASED C&Q – PART 1 1. Outline of the execution flow of validation for the project that follows from the Lean Qualification Approach (LQA) Based on the LQA, to prepare the whole validation document for the…

{ENGLISH} CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – END

CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – END 13. Comparison between “U” & “I” Layout The choice between U shape layout and I shape layout depends on the specific needs of the…