Lanny, Author at CMPlus

Profil Penulis

lanny s

Latar belakang pendidikan adalah teknik kimia (S1 dan S2). Bergabung dengan CTCI Corporation (perusahaan EPC Taiwan) sebagai Piping Engineer di tahun 2008. Bergabung dengan Alfa Laval Malaysia Sdn. Bhd. (perusahaan Swedia) sebagai Project Manager dari South East Asia Regional Competence Centre (SEA RCC) di tahun 2012. Bergabung dengan CM Plus Corporation sebagai Project Engineer di tahun 2015.

{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…

{ENGLISH} CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 2

CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 2 7. How to Plan a Plant Planning a pharmaceutical factory involves several important steps from design concept to basic design. Here is a sequence…