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.
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…
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…
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…
CHAPTER 3 QUALITY SYSTEM AND GMP – PART 1 1. Introduction Quality control technology introduced by the U.S. in the postwar period. Japan has developed QC activities in the general industry and developed to TQM (Total Quality Management) in…
