Pharmaceutical Quality Control Lab Guidebook PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Pharmaceutical Quality Control Lab Guidebook PDF full book. Access full book title Pharmaceutical Quality Control Lab Guidebook by Daniel Farb. Download full books in PDF and EPUB format.
Author: Daniel Farb Publisher: UniversityOfHealthCare ISBN: 1594912610 Category : Medical Languages : en Pages : 100
Book Description
Pharmaceutical Quality Control Lab teaches the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with results in a pharmaceutical lab. It contains an interactive flow chart, numerous step-by-step instructions, questions, SOP model, and a case study. It is suitable for GMP training.
Author: Daniel Farb Publisher: UniversityOfHealthCare ISBN: 1594912610 Category : Medical Languages : en Pages : 100
Book Description
Pharmaceutical Quality Control Lab teaches the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with results in a pharmaceutical lab. It contains an interactive flow chart, numerous step-by-step instructions, questions, SOP model, and a case study. It is suitable for GMP training.
Author: Daniel Farb Publisher: Universityofhealthcare ISBN: 9781932634686 Category : Medical Languages : en Pages : 61
Book Description
Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance and the goes into the specifics of dealing with out of standard and out of trend in a pharmaceutical quality control lab.
Author: Institute of Quality Assurance. Pharmaceutical Quality Group Publisher: ISBN: 9780906810798 Category : Medical laboratories Languages : en Pages : 104
Author: Kim Huynh-Ba Publisher: John Wiley & Sons ISBN: 1119120918 Category : Science Languages : en Pages : 420
Book Description
Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author: Kim Huynh-Ba Publisher: John Wiley & Sons ISBN: 1119680433 Category : Science Languages : en Pages : 420
Book Description
Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author: Philip Carson Publisher: Royal Society of Chemistry ISBN: 1847557724 Category : Science Languages : en Pages : 656
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author: Syed Imtiaz Haider Publisher: CRC Press ISBN: 143985016X Category : Medical Languages : en Pages : 484
Book Description
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Author: Anthony Luttrell Publisher: Universityofhealthcare ISBN: 9781594910371 Category : Medical Languages : en Pages : 61
Book Description
Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with out of standard and out of trend results in a pharmaceutical quality control lab. It contains an interactive flow chart, numerous step -by-step instructions, questions, an SOP model, and a case study. It is suitable for GMP training. Estimated time: 2-5 hours. 199 pages on CD. 61 pages in the manual include a handy printout of the FDA regulations part 210 and part 211. For convenience, the CD contains the text of some of the regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
Author: Daniel Farb
Author: Daniel Farb
Author: Daniel Farb
Author: Scott Sutton
Author: Institute of Quality Assurance. Pharmaceutical Quality Group
Author: Kim Huynh-Ba
Author: Kim Huynh-Ba
Author: Murray Sam Cooper
Author: Philip Carson
Author: Syed Imtiaz Haider
Author: Anthony Luttrell