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 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…

{ENGLISH} CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 1

CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 1 This summary emphasizes the importance of URS and CD in establishing specifications and quality in the early stages of the project. 1. Prologue…

{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – END

CHAPTER 4 VALIDATION AND QUALIFICATION – END 7. Validation Master Plan (VMP) The PIC/S guide dives deep into Installation and Operational Qualification (IQ/OQ) and Non-Sterile Process Validation, but it all starts with a crucial document: the Validation Master…

{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – PART 2

CHAPTER 4 VALIDATION AND QUALIFICATION – PART 2 5. Structure of Process Validation The purpose of process validation is to “scientifically verify that a drug product of stable quality can be reproducibly produced. The new FDA definition…