Essential Elements for a GMP Analytical Chemistry Department 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 Essential Elements for a GMP Analytical Chemistry Department PDF full book. Access full book title Essential Elements for a GMP Analytical Chemistry Department by Thomas Catalano. Download full books in PDF and EPUB format.
Author: Thomas Catalano
Publisher: Springer Science & Business Media
ISBN: 1461476429
Category : Medical
Languages : en
Pages : 203
Get Book Here
Book Description
Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies.
Author: Thomas Catalano
Publisher: Springer Science & Business Media
ISBN: 1461476429
Category : Medical
Languages : en
Pages : 203
Get Book Here
Book Description
Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies.
Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 0081028253
Category : Science
Languages : en
Pages : 696
Get Book Here
Book Description
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Author: Thomas Catalano
Publisher: Springer
ISBN: 3319097253
Category : Medical
Languages : en
Pages : 82
Get Book Here
Book Description
Good Laboratory Practices for Forensic Chemistry acknowledges the limitations that often challenge the validity of data and resultant conclusions. Eight chapters examine current practices in analytical chemistry as well as business practices, guidelines and regulations in the pharmaceutical industry to offer improvements to current practices in forensic chemistry. It discusses topics ranging from good manufacturing practices (GMP), good laboratory practices (GLP), the International Conference on Harmonisation (ICH), quality assurance (QA), and quality risk management (QRM), among others. This book is a guide for scientists, professors, and students interested in expanding their knowledge of forensic chemistry.
Author: Thomas Catalano
Publisher: Springer Nature
ISBN: 3030575276
Category : Medical
Languages : en
Pages : 79
Get Book Here
Book Description
Dr. Catalano has for the last ten years been doing consulting for the Pharmaceutical Industry. During his consulting he discovered that small businesses such as, generic, startups, and virtual companies do not have the budget or the resources to apply the computer software utilized in project management and therefore do not apply project management principles in their business model. This reduces their effectiveness and increases their operating cost. Application of Project Management Principles to the Management of Pharmaceutical R&D Projects is presented as a paper-based system for completing all the critical activities needed apply the project management system. This will allow these small business to take advantage of the project management principles and gain all the advantages of the system. This book will be beneficial for beginners to understand the concepts of project management and for small pharmaceutical companies to apply the principles of project management to their business model.
Author: Stig Pedersen-Bjergaard
Publisher: John Wiley & Sons
ISBN: 1119362725
Category : Science
Languages : en
Pages : 546
Get Book Here
Book Description
Die umfassend überarbeitete 2. Auflage enthält ein neues Kapitel zur chemischen Analyse von Biopharmazeutika, in dem die Identifizierung, Reinheitsprüfung und die Analyse on Peptiden und proteinbasierten Formulierungen erläutert werden. Die neue Auflage bietet ebenfalls verbesserte farbige Abbildungen und Tabellen, eine gestraffte Kapitelstruktur und überarbeitete Inhalte, die das Fachgebiet klarer und verständlicher präsentieren. - Bietet eine Einführung in die grundlegenden Konzepte der pharmazeutischen analytischen Chemie und Statistik. - Untersucht systematisch pharmazeutische Anwendungen, die in anderen Lehrbüchern zu dem Fachgebiet fehlen. - Untersucht verschiedene Analysetechniken, die in der Regel in Pharmalaboren zur Anwendung kommen. - Präsentiert Fragestellungen aus der Praxis, aktuelle praktische Beispiele und detaillierte Illustrationen. - Die aktualisierten Inhalte entsprechen den aktuellen europäischen und US-amerikanischen Arzneibuchvorschriften und -richtlinien.
Author: John K. Taylor
Publisher: Routledge
ISBN: 1351420747
Category : Science
Languages : en
Pages : 353
Get Book Here
Book Description
This definitive new book should appeal to everyone who produces, uses, or evaluates scientific data. Ensures accuracy and reliability. Dr. Taylor's book provides guidance for the development and implementation of a credible quality assurance program, plus it also provides chemists and clinical chemists, medical and chemical researchers, and all scientists and managers the ideal means to ensure accurate and reliable work. Chapters are presented in a logical progression, starting with the concept of quality assurance, principles of good measurement, principles of quality assurance, and evaluation of measurement quality. Each chapter has a degree of independence so that it may be consulted separately from the others.
Author:
Publisher:
ISBN:
Category : Electronic journals
Languages : en
Pages : 910
Get Book Here
Book Description
Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119121116
Category : Science
Languages : en
Pages : 256
Get Book Here
Book Description
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
Author: Gauri Misra
Publisher: CRC Press
ISBN: 1040004369
Category : Medical
Languages : en
Pages : 209
Get Book Here
Book Description
This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives. Key Features: Reviews various scientific and regulatory aspects involved in the quality control of biologicals Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes Explores the use of animal-based testing methods in quality control, as well as their alternatives Discusses guidelines and methodologies involved in the development of biological products Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals.
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
Get Book Here
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
