Quality Rules In Active Pharmaceutical Ingredients Manufacture
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Quality Rules In Active Pharmaceutical Ingredients Manufacture
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Author : John Sharp
language : en
Publisher: Interpharm CRC
Release Date : 2002
Quality Rules In Active Pharmaceutical Ingredients Manufacture written by John Sharp and has been published by Interpharm CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Medical categories.
The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of active pharmaceutical ingredients (APIs). Drawing on the guidelines prepared under the ICH and made available by the US FDA, this booklet covers all the cGMP concepts required as training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. In his familiar, no-nonsense style, the author explains the rationale of cGMP and the key role played by workers in the production and packaging of pure, safe, and quality APIs.
Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher:
Release Date : 2010
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Drug development categories.
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products
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Author : Ashish Dey
language : en
Publisher: NIIR PROJECT CONSULTANCY SERVICES
Release Date : 2023-01-05
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products written by Ashish Dey and has been published by NIIR PROJECT CONSULTANCY SERVICES this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-05 with Antiques & Collectibles categories.
An active pharmaceutical ingredient (API) is the active substance in a pharmaceutical drug that produces its therapeutic effect. APIs can be synthetic chemicals or natural sources such as plant extracts. APIs are components of drugs, the majority of which are manufactured by pharmaceutical companies. Drugs, on the other hand, are dosage forms that contain an API and are distributed to patients for use. Pharmaceutical products are any compounds used in the medical industry to diagnose, treat, cure, or prevent diseases. These products are typically formulated as drugs, vaccines, biologics, and medical devices, which can either be prescribed by a doctor or bought over-the-counter (OTC). They come in various forms such as tablets, capsules, syrups, ointments, creams, solutions, suspensions, implants, patches, and powders. Pharmaceutical products are manufactured under strict guidelines and must adhere to various regulations such as Good Manufacturing Practices (GMP). The global market for Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products is expected to grow rapidly over the next few years. This growth will be driven by rising demand for improved healthcare services and an increasing number of new treatments. The market for active pharmaceutical ingredients is anticipated to rise at a CAGR of 5.90%. The development in the production of active pharmaceutical ingredients (APIs) as well as the increased incidence of chronic diseases including cancer and cardiovascular conditions are both responsible for the expansion. Government regulations that are supportive of API manufacturing, together with shifting geopolitical conditions, are accelerating market expansion. The pharmaceutical products market has grown steadily in recent years, and is expected to continue to do so. This growth is driven by a number of factors, including increased demand for new drugs, changing disease patterns and aging populations in some countries, as well as the emergence of innovative drugs and technologies. The market is being shaped by the rise of emerging economies and their increasing healthcare needs. This has led to increased investment in drug research and development, as well as an increase in the number of multinational companies setting up operations in various countries. Furthermore, generic drugs are becoming increasingly popular as a way of reducing healthcare costs. Generic drugs are copies of brand-name drugs, which are manufactured by generic drug companies. They offer an effective alternative to branded drugs and are often much cheaper. As a result, generic drugs are increasingly being used in countries across the world, leading to an increase in the global pharmaceutical products market. Overall, the global market for pharmaceutical products and drugs are set to continue to grow in the coming years. New products, innovative technologies and emerging markets will drive growth, and this will bring both opportunities and challenges for the industry. The books' main subjects include Active Pharmaceutical Ingredients (API), Drugs, Aspirin, Paracetamol, IV Fluids, Ointment, Metronidazole, Liquid Glucose, Surgical Cotton, Syrup, Tablet, Excipients, Pharmaceutical Salts with formulations, factory layout, and images of machinery with contact information for suppliers. A thorough guide to manufacturing and business operations in the Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products industry. The Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products manufacturing industry is full with opportunity for producers, traders, and business owners, and this book is your one-stop resource for all the information you require. The only complete manual on the creation of commercial Active Pharmaceutical Ingredients (API), medications, and pharmaceutical products is this one. It offers a wealth of information on how to do things, from concept through equipment acquisition.
Quality Assurance Of Pharmaceuticals
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2004
Quality Assurance Of Pharmaceuticals written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Business & Economics categories.
Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).
Pharmaceutical Vendors Approval Manual
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Author : Erfan Syed Asif
language : en
Publisher: CRC Press
Release Date : 2021-12-12
Pharmaceutical Vendors Approval Manual written by Erfan Syed Asif and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-12 with Business & Economics categories.
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Basics Of Pharmaceutical Manufacturing And Quality Operations
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Author : Erfan Syed Asif
language : en
Publisher: CRC Press
Release Date : 2024-03-14
Basics Of Pharmaceutical Manufacturing And Quality Operations written by Erfan Syed Asif and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-14 with Business & Economics categories.
This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry. Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both sterile and non‐sterile areas. The book is a simple, concise, and easy to use reference tool covering basic quality concepts required by the pharmaceutical educational institutions and professional certification bodies. It describes details of all GXP activities that are directly related to Quality, Safety, and Efficacy of the products manufactured under the umbrella of Quality Operations, common testing methods which are used in any modern industry, Requirements of Validation and Qualification of equipment, facilities and processes, integral segments of Drug product manufacturing, storage, and distribution practices. The material provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product to enhance the GMP within the industry. The book is written with the idea of providing basic knowledge to undergraduate students who are preparing to enter the industry at the end of their graduation. The book would also be beneficial for institutions conducting pharmaceutical technology study courses in terms of GMP and GLP applications. Features: Provides readers and front line health care product manufacturers, all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. Provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product and packaging material to enhance the GMP within the industry. Includes significant processes and steps in production for all common dosage forms. Explains how in‐process and finished products are released. Provides an ideal and effective tool for anyone starting Quality Assurance/Quality control/Production responsibilities.
Validation Of Bulk Pharmaceutical Chemicals
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Author : Daniel Harpaz
language : en
Publisher: Interpharm CRC
Release Date : 1997-01-01
Validation Of Bulk Pharmaceutical Chemicals written by Daniel Harpaz and has been published by Interpharm CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-01-01 with Medical categories.
Fourteen contributions offer definitive guidance to both the manufacturer and the purchaser of bulk pharmaceutical chemicals on the legal, regulatory, and manufacturing process for active pharmaceutical ingredients and excipients. The text emphasizes validation, the key element of good manufacturing practice, with information from a group of industry experts on facilities, procedures, quality assurance, and other functions. Acceptable and achievable practices and regulatory requirements of the dosage form sector of the pharmaceutical industry are related to the bulk pharmaceutical chemical (BPC) producer in chapters which cover topics such as: the legal framework for the regulation of BPCs, drug master files, quality assurance systems, and vendor qualification and certification. Annotation copyrighted by Book News, Inc., Portland, OR
Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2005-05-25
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-05-25 with Medical categories.
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
Manufacturing Of Quality Oral Drug Products
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Author : Sam A. Hout
language : en
Publisher: CRC Press
Release Date : 2022-06-27
Manufacturing Of Quality Oral Drug Products written by Sam A. Hout and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-06-27 with Technology & Engineering categories.
This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.