Quality Control (QC) is important to ensure the identity, strength, purity, pharmacological safety, efficacy, and effectiveness of biopharmaceutical products. Biopharmaceuticals are complex drugs that are created from living cells or organisms, which frequently employ advanced biotechnological techniques. In the biopharmaceutical industry, tests are performed on the finished product to ensure t…
Quality Control (QC) is part of the quality assurance system and holds a critical activity of ensuring drug products' safety, efficacy, and quality fulfill the requirement. Current Good Manufacturing Practice (cGMP) is a standard regulation enforced by the Food and Drug Administration (FDA) to guarantee product quality and must be followed by all pharmaceutical companies. One of the crucial com…
PT. Saraswanti Indo Genetech is a laboratory company that provides detection services for quality control for other companies that need permission from BPOM to commercialize their product. This project is one of the company’s projects for expanding its scope of services. The project’s goal is to identify the problem in growing the positive control of the IFU (The International Fruit…
MIlk is considered as one of the most nutritious drinks produced by mammals. However, milk is also perishable due to its nature. In the milk industry, heat treatment, such as Ultra HIgh Temperature (UHT) is commonly applied to extend the shelf life of the milk and inactivate unwanted microorganisms and undesirable enzymes. UHT treatment sterilizes the milk from the presence of vegetative ce…
Established in 1973 by Ir. Wanne Mardiwidyo, PT Meprofarm is an Indonesian pharmaceutical company based in Bandung that always prioritizes achieving quality in producing products. Meprofarm has 2 main production facilities which are MEPRO-1 and MEPRO-2. MEPRO-1 focuses on producing solid dosage forms of non-beta lactam, beta lactam penicillin, and beta lactam cephalosporin. Meanwhile, MEPRO-…
Kalbio Global Medika (KGM) which is a subsidiary of PT Kalbe Farma is one of the primary pharmaceutical companies in Indonesia specializing in the manufacture of sterile parenteral drug products which was built up in 2014. The quality control (QC) department of KGM is divided into five which are Raw material, Microbiology, Finished goods and intermediate, Compliance and Test item control. I…
Water is a crucial component used for substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. Due to its unique chemical properties, water is able to dissolve or suspend many different contaminants that might react to the intended product substance. Therefore, monitoring water quality is important. Water in PT Kalbio Global Medika a…
After a sordid litany of recalls courtesy of the food industry, consumers are pointing the finger at companies that have failed to institute proper recall prevention techniques. While historical analysis shows no company is exempt from recall risk, most can be prevented with an efficient and verifiable quality control program. Authored by a 20-year food management specialist, Food Industry Q…
This book is today's most complete and results-based reference to the tools and concepts needed to understand, implement, and leverage Lean Six Sigma. The only guide that groups tools by purpose and use, this hands-on reference provides analyses of nearly 100 tools and methodologies-from DMAIC and Pull Systems to Control Charts and Pareto Charts.
For undergraduate and graduate-level courses in Quality Control, Statistical Process Control, Quality Improvement, and Quality Assurance. This book will be valuable in programs such as Quality Improvement, Lean Six Sigma, Quality Control, and Statistical Process Control; in Associate Degree in Quality and other technical programs; in Baccalaureate programs in Engineering, Technology, Health Car…
Food materials are processed prior to their consumption using different processing technologies that improve their shelf life and maintain their physicochemical, biological, and sensory qualities. Introduction to Advanced Food Process Engineering provides a general reference on various aspects of processing, packaging, storage, and quality control and assessment systems, describing the basic pr…
The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisf…
Value Proposition Design helps you tackle a core challenge of every business — creating compelling products and services customers want to buy. This practical book, paired with its online companion, will teach you the processes and tools you need to succeed. Using the same stunning visual format as the authors’ global bestseller, Business Model Generation, this sequel explains how to use t…