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 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 2

CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 2 7. How to Plan a Plant Planning a pharmaceutical factory involves several important steps from design concept to basic design. Here is a sequence…

{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),…