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Author: Thomas Catalano Publisher: Springer Science & Business Media ISBN: 1461476429 Category : Medical Languages : en Pages : 203
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
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: José Rodríguez-Pérez Publisher: Quality Press ISBN: 0873898699 Category : Business & Economics Languages : en Pages : 246
Book Description
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author: Ludovico Dragoni Publisher: Ludovico Dragoni ISBN: Category : Computers Languages : en Pages : 85
Book Description
In the dynamic world of pharmaceutical technology, ensuring the safety, efficacy and quality of products is more important than ever. At the intersection of technological innovation and strict regulatory compliance lies computer system validation (CSV), an essential but often misunderstood element. This volume is an indispensable guide to navigating the intricate facets of CSV, and outlines the most important aspects of CSV with clarity and precision. Discussed are the regulatory foundations, exploration of the main players and involved processes, key concepts of validation, risk-based approach, up to future projections and the incorporation of emerging technologies. Finally, practical advice drawn from my own experience will also be provided, including resources, blogs and websites that I have found extremely useful. Whether you are starting from scratch and want a solid foundation, or are already familiar with the subject but want to fill in some gaps, this book will provide you with a comprehensive and detailed overview of the world of CSV.
Author: Shanti Bhushan Mishra Publisher: Educreation Publishing ISBN: Category : Education Languages : en Pages : 320
Book Description
Essentials of Herbal Drug Technology is a unique attempt to arouse the interest of students in this fast developing branch of pharmacy i.e. Pharmacognosy and related fields like herbal medicine, natural products and their standardization because increasing interest in the field of herbal medicine and ayurvedic dosage forms; their standardization is utmost required. The Book provides in depth information about various guidelines of different regulatory bodies that are required in quality control of herbal drugs. This book has been written with the object that the new syllabus of the Bachelor in Pharmacy, Master in Pharmacy and doctorate in herbal medicines and their pharmacological efficacy as per PCI course curriculum is covered in reasonable detail to provide sound scientific knowledge of quality control and standardization.
Author: Thomas Catalano
Author: Thomas Catalano
Author: Michael Cutter
Author: Michael Cutter
Author: Michael Cutter
Author: José Rodríguez-Pérez
Author: Michael Cutter
Author: Ludovico Dragoni
Author: Shanti Bhushan Mishra
Author: Michael Cutter
Author: Vesper