식품의약품안전처  | 진한엠앤비

30,600원  | 20250110  | 9791129057570

진한엠앤비에서 출간한 도서로 화장품학 정보를 다룬다. 우수화장품 제조 및 품질관리기준(CGMP)에 대해 상세한 내용을 확인할 수 있다.

식품의약품안전처  | 진한엠앤비

18,000원  | 20160329  | 9791170094241

『우수화장품 제조 및 품질관리기준(CGMP) 해설서』는 우수화장품 제조 및 품질관리 기준에 관한 세부사항을 정하고, 이를 이행하도록 권장함으로써 우수한 화장품을 제조·공급하여 소비자보호 및 국민 보건 향상에 기여함을 목적으로 하는 책이다.

 | CRC Press

0원  | 20250523  | 9781498700306

This book serves as an engineering resource for the manufacturing process development, scale-up, and commercial scale production of biopharmaceutical compounds (i.e., biologics such as proteins, DNA, and viruses) in a current good manufacturing (cGMP) environment. Offering a holistic view of the biologics manufacturing process, the text provides a technical roadmap governing all aspects of the manufacturing process once a biologic has been identified for clinical testing and possible commercialization, including quality control/quality assurance and regulatory submission.

식품의약품안전처  | 진한엠앤비

24,750원  | 20180310  | 9791129003607

『우수화장품 제조 및 품질관리기준(CGMP) 해설서 2018』은 우수화장품 제조 및 품질관리 기준에 관한 세부사항을 정하고, 이를 이행하도록 권장함으로써 우수한 화장품을 제조·공급하여 소비자보호 및 국민 보건 향상에 기여함을 목적으로 한다. CGMP는 품질이 보장된 우수한 화장품을 제조·공급하기 위한 제조 및 품질관리에 관한 기준으로서 직원, 시설·장비 및 원자재, 반제품, 완제품 등의 취급과 실시방법을 정한 것이다. CGMP 3대 요소 ① 인위적인 과오의 최소화 ② 미생물오염 및 교차오염으로 인한 품질저하 방지 ③ 고도의 품질관리체계 확립 화장품 제조업체에서 화장품 제조 및 품질관리 시 CGMP 이행을 통하여 전반적으로 발생할 수 있는 위험과 잠재적인 문제를 상당히 감소시켜 유통화장품 품질 확보에 따른 소비자 보호 및 국민 보건 향상에 기여할 수 있을 것으로 기대되고, 생산성 향상도 기대할 수 있을 것이다.

 | KS OmniScriptum Publishing

91,870원  | 20250512  | 9786208445041

GMP is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take protective steps to ensure that their products are safe, pure, and effective.

Muchemu, David N.  | Lightning Source Inc

88,200원  | 20210101  | 9781434348722

This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device,Pharmaceutical,Tissue,and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485,and ISO 9001 5.It provides standard definitions for the Quality management system 6.

Gee, Adrian  | Springer

367,480원  | 20090925  | 9780387895833

Cell Therapy offers a discussion of facility design operation issues, complete with practical approaches.

Dongare, Trupti Patil  | BSP Books Pvt. LTD.

174,560원  | 20191203  | 9789388305143

This handbook has been written for the students of pharmacy and pharmaceutical industry. It gives pocket guide of good manufacturing practices in pharmaceutical industry. The purpose of this handbook is to provide easily accessible knowledge about the pharmaceutical industry and to assist individuals to know about pharmaceutical world.This handbook has also incorporated the current trends and expectations of the evolving pharmaceutical industry and regulatory oversight.

Bliesner, David M.  | Wiley

225,930원  | 20060421  | 9780471738404

Establishing a CGMP Laboratory Audit System: A Practical Guide guides the reader through establishing a Current Good Manufacturing Practices laboratory audit system using detailed flowcharts, checklists, and descriptions of the process. Templates and checklists on a CD-ROM provide for easy use and modification in the laboratory.

Mark A Brown  | Wiley

78,260원  | 20140415  | 9781118396612

Beginning with the untimely death of a young mother, this book unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences.

 | BSP Books Pvt. LTD.

330,750원  | 20190701  | 9789387593442

Indian pharmaceutical industry is becoming global at high pace. This resulted in high pressure on the industry for quality products and practices. Thus cGMP has acclaimed Key position.Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.Salient features? All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.

 | CRC Press

0원  | 20011231  | 9780849318290

The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources.