GMP Archives - Page 2 of 6

{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…

{ENGLISH} CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 1

CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 1 About Pharmaceuticals The pharmaceutical, also called “medicine” or “drug”, can be divided into: 1. Prescription-only drugs Prescription-only drugs can be defined by purposes of use as the following: For doctors…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – GLOSARIUM ANEKS 3

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – GLOSARIUM ANEKS 3 NO VERSI ASLI VERSI TERJEMAHAN Preparation: handling and radiolabelling of kits with radionuclide eluted from generators or radioactive precursors within a hospital. Kits, generators and precursors should have a marketing authorisation or a…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – DISTRIBUSI

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – DISTRIBUSI NO VERSI ASLI VERSI TERJEMAHAN 51 Distribution of the finished product under controlled conditions, before all appropriate test results are available, is acceptable for radiopharmaceuticals, providing the product is not administered by the receiving institute…