Calibration in the Pharmaceutical Laboratory PDF Download
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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
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: 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: Parviz Bayegi
Publisher: Independently Published
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 0
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Book Description
Preface This book provides extensive information about GMP calibrations according to EU-GMP/FDA guidelines for the pharmaceutical industry and laboratories. The book is suitable for personnel in the field of QA, QC pharmaceutical production and chemical laboratories as well as for students and trainees from the fields of chemistry, pharmaceutical industry, and pharmaceutical engineering. Have fun and congratulations to the reader. Your Parviz Bayegi
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: 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: Jay L. Bucher
Publisher: Quality Press
ISBN: 0873897048
Category : Business & Economics
Languages : en
Pages : 190
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Book Description
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: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 1118060318
Category : Science
Languages : en
Pages : 416
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Book Description
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
