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…

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…

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),…

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…

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…

FDA BATASI PENGGUNAAN ANTIBODI MONOKLONAL UNTUK COVID-19 DIKARENAKAN VARIAN OMICRON   Selama pandemi Covid-19 ini, FDA telah membuat banyak keputusan dengan mempertimbangkan kesehatan dan keselamatan rakyat Amerika Serikat. Keputusan tersebut didasarkan pada penggunaan ilmu pengetahuan yang ada sejalan dengan perkembangan virus.   Berdasarkan informasi…