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Author: Tony Kowalski
Publisher: CRC Press
ISBN: 9781574910926
Category : Medical
Languages : en
Pages : 336
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Book Description
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process.
Author: Tony Kowalski
Publisher: CRC Press
ISBN: 9781574910926
Category : Medical
Languages : en
Pages : 336
Get Book Here
Book Description
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process.
Author: Vinay Bhatt
Publisher: CRC Press
ISBN: 9781574910773
Category : Medical
Languages : en
Pages : 528
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Book Description
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 047146371X
Category : Science
Languages : en
Pages : 320
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Book Description
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Author: Shiv Shankar Shukla
Publisher: Springer Nature
ISBN: 9811990026
Category : Medical
Languages : en
Pages : 216
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Book Description
This up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ‘Validation of herbals’ considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
Author: Jay L. Bucher
Publisher: Quality Press
ISBN: 9780873897044
Category : Business & Economics
Languages : en
Pages : 216
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Book Description
If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen. This book is about how to design, implement, maintain, and continuously improve a quality calibration system, with all the required documentation, traceability, and known uncertainty for each and every item of test equipment owned and used by any company, large or small. It will benefit companies that want to implement a program and also those that already have one in place. Some industries have tighter requirements than others on how they treat calibration; some are more specific about how their standards are read, while being vague about what is needed to meet calibration. Is there one tried-and-true quality calibration system that every organization can use as a foundation for its personalized program? There certainly is, and The Quality Calibration Handbook describes it. By using the quality calibration system outlined and demonstrated, any organization can put together its own version to meet its specific requirements and/or regulations. Quality calibration systems are the very foundation for improving research and development (R&D), production, and quality assurance arenas through accurate, reliable, and traceable calibrations of their test equipment. By ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes, the guilty are often caught and the innocent exonerated. Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters. At pharmaceutical companies, calibration technicians quietly lay the foundation for quality treatments that help keep us healthy, cure diseases, and sometimes prevent death. This book explains why a quality calibration system can be the difference between life and death, success and failure, andmost important to shareholders and boards of directorsprofit and loss. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating (5 of 5 based on 4 reviews) "This book offers me the information I need to upgrade the quality of the service I provide to customers. It makes the quantum leap between the theory and practice in calibration. I needed this applicable and practical information a long time ago." A reader in Anchorage, Alaska "This book is a great and simple reference guide for developing a world class calibration system. If you are thinking about revamping your calibration system or developing one, this book is a must. This book is written by a person sharing his practical experience to less experienced people." A reader in Austin, Texas "Excellent reference for setting up a calibration program or improving your current operations. This book is a must read for anyone working in the metrology field." A reader in Springboro, Ohio "This book is for anyone who wants to learn more about the requirements of a good calibration program. It gives easy to understand guidelines and practical advice to help you make your calibration program world class." A reader in Putnam, Connecticut
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080455182
Category : Medical
Languages : en
Pages : 679
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Book Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author: Kim Huynh-Ba
Publisher: John Wiley & Sons
ISBN: 1119680433
Category : Science
Languages : en
Pages : 420
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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: University of Wisconsin. Department of Pharmacy
Publisher:
ISBN:
Category : Pharmacy
Languages : en
Pages : 56
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Book Description
Author: B.P. Nagori
Publisher: Scientific Publishers
ISBN: 938774101X
Category : Medical
Languages : en
Pages : 280
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Book Description
he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses.
Author: Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe
Publisher: Shashwat Publication
ISBN: 936087258X
Category : Medical
Languages : en
Pages : 290
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Book Description
The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evolution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple-Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
