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{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…

{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – PART 1

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…

{ENGLISH} CHAPTER 3 QUALITY SYSTEM AND GMP – PART 2 (END)

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…