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{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…

{ENGLISH} CHAPTER 3 QUALITY SYSTEM AND GMP – PART 1

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…

{ENGLISH} CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 2 (END)

CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 2 (END) 6. PIC/S to become a Global Standard The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good…

{ENGLISH} CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 1

CHAPTER 2 HISTORY OF GMP AND INTERNATIONAL HARMONIZATION – PART 1 1. Birth of GMP In 1938, the Food, Drug, and Cosmetic Act (FD&C Act) was passed in USA. In 1962, a major amendment to the FD&C Act was…

{ENGLISH} CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 3 (END)

CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 3 (END) Drug Product Manufacture Facility For the manufacture facility, drugs can be divided into sterile products (Injection, Eye Drop, Eye ointment, Nasal drops) and non-sterile products (Tablet, capsule, powder, liquid (Oral Solid Dosage),…

{ENGLISH} CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 2

CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 2 Pharmaceutical Manufacture Facilities The production process of drugs can be mainly divided into: “API process”, which produces active pharmaceutical ingredients of drugs. “Formulation process”, which turns API into an…