Lanny, Author at CMPlus

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lanny s

Latar belakang pendidikan adalah teknik kimia (S1 dan S2). Bergabung dengan CTCI Corporation (perusahaan EPC Taiwan) sebagai Piping Engineer di tahun 2008. Bergabung dengan Alfa Laval Malaysia Sdn. Bhd. (perusahaan Swedia) sebagai Project Manager dari South East Asia Regional Competence Centre (SEA RCC) di tahun 2012. Bergabung dengan CM Plus Corporation sebagai Project Engineer di tahun 2015.

{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…

FDA BATASI PENGGUNAAN ANTIBODI MONOKLONAL UNTUK COVID-19 DIKARENAKAN VARIAN OMICRON

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…

FDA Setujui Penggunaan Obat Dwarfisme Pertama

FDA SETUJUI PENGGUNAAN OBAT DWARFISME PERTAMA FDA menyetujui penggunaan injeksi voxzogo (vosoritide) untuk meningkatkan pertumbuhan anak – anak berusia lima tahun keatas dengan achondroplasia dan epifisis terbuka (open epiphyses), yang berarti anak – anak tersebut masih memiliki potensi untuk tumbuh. Achondroplasia merupakan jenis dwarfisme yang…