Essential Elements for a GMP Analytical Chemistry Department - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Essential Elements for a GMP Analytical Chemistry Department write by Thomas Catalano. This book was released on 2013-06-20. Essential Elements for a GMP Analytical Chemistry Department available in PDF, EPUB and Kindle. 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.
Analytical Chemistry in a GMP Environment
Analytical Chemistry in a GMP Environment - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Analytical Chemistry in a GMP Environment write by James M. Miller. This book was released on 2000-05. Analytical Chemistry in a GMP Environment available in PDF, EPUB and Kindle. Based on the Laboratory Analyst Training and Certification Program ... chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly .... Among the topics are the drug development process, uniform and consistent interpretation of compliance issues, the role of statistics and basic topics in analytical chemistry, and detectors and quantitative analysis. The emphasis is on high-performance liquid chromatographic methods.
Specification of Drug Substances and Products
Specification of Drug Substances and Products - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Specification of Drug Substances and Products write by Christopher M. Riley. This book was released on 2020-07-23. Specification of Drug Substances and Products available in PDF, EPUB and Kindle. 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
Good Laboratory Practices for Forensic Chemistry
Good Laboratory Practices for Forensic Chemistry - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Good Laboratory Practices for Forensic Chemistry write by Thomas Catalano. This book was released on 2014-09-02. Good Laboratory Practices for Forensic Chemistry available in PDF, EPUB and Kindle. 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.
Application of Project Management Principles to the Management of Pharmaceutical R&D Projects
Application of Project Management Principles to the Management of Pharmaceutical R&D Projects - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Application of Project Management Principles to the Management of Pharmaceutical R&D Projects write by Thomas Catalano. This book was released on 2020-11-05. Application of Project Management Principles to the Management of Pharmaceutical R&D Projects available in PDF, EPUB and Kindle. 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.
