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…

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…

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…

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…

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…

CHAPTER 4 VALIDATION AND QUALIFICATION – PART 1   1. Introduction Thorough quality control is required in the manufacture of pharmaceuticals, which can affect human lives. Quality control is important but not only that, therefore it is necessary to prove…