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{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…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – SAMPEL REFERENSI DAN PERTINGGAL

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – SAMPEL REFERENSI DAN PERTINGGAL NO VERSI ASLI VERSI TERJEMAHAN 48 For radiopharmaceuticals sufficient samples of each batch of bulk formulated product should be retained for at least six months after expiry of the finished medicinal product…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENGAWASAN MUTU

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 39 Some radiopharmaceuticals may have to be distributed and used on the basis of an assessment of batch documentation and before all chemical and microbiology tests have been completed.

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRODUKSI

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRODUKSI NO VERSI ASLI VERSI TERJEMAHAN 34 Production of different radioactive products in the same working area (i.e. hot-cell, LAF unit), at the same time should be avoided in order to minimise the risk of cross-contamination…