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…

CHAPTER 3 QUALITY SYSTEM AND GMP – PART 2 (END)   4. Pharmaceutical Quality System (PQS) ICH introduced PQS in 2010 as an independent system for the first time. The objective is to improve the quality assurance level of pharmaceutical…