Pharmaceutical Manufacturing Handbook PDF Download
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Author | : Shayne Cox Gad |
Publisher | : John Wiley & Sons |
Total Pages | : 1384 |
Release | : 2008-03-21 |
Genre | : Science |
ISBN | : 0470259809 |
Download Pharmaceutical Manufacturing Handbook Book in PDF, ePub and Kindle
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author | : Shayne Cox Gad |
Publisher | : John Wiley & Sons |
Total Pages | : 857 |
Release | : 2008-04-04 |
Genre | : Science |
ISBN | : 0470259825 |
Download Pharmaceutical Manufacturing Handbook Book in PDF, ePub and Kindle
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Author | : Safaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 458 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1420081314 |
Download Handbook of Pharmaceutical Manufacturing Formulations Book in PDF, ePub and Kindle
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
Author | : |
Publisher | : American Bar Association |
Total Pages | : 484 |
Release | : 2009 |
Genre | : Antitrust law |
ISBN | : 9781604425628 |
Download Pharmaceutical Industry Antitrust Handbook Book in PDF, ePub and Kindle
Author | : Sarfaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 769 |
Release | : 2019-12-06 |
Genre | : Medical |
ISBN | : 1351594907 |
Download Handbook of Pharmaceutical Manufacturing Formulations, Third Edition Book in PDF, ePub and Kindle
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Author | : Shayne Cox Gad |
Publisher | : Wiley-Interscience |
Total Pages | : 0 |
Release | : 2008-03-28 |
Genre | : Science |
ISBN | : 9780471213918 |
Download Pharmaceutical Manufacturing Handbook, 2 Volume Set Book in PDF, ePub and Kindle
Pharmaceutical Manufacturing Handbook covers a range of topics to help professionals better understand the methods used in the pharmaceutical manufacturing, pharmaceutical engineering, and process engineering fields. It covers many aspects, such as the building of a facility, to the various dosage and delivery forms available, and finally to the principles of validation. Other topics include quality assurance and regulatory requirements. Without exposure to all of these topics, professionals and others in the various pharmaceutical fields will not be able to produce quality drugs.
Author | : Jordi Botet |
Publisher | : Bentham Science Publishers |
Total Pages | : 504 |
Release | : 2015-09-28 |
Genre | : Medical |
ISBN | : 1681081148 |
Download Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook Book in PDF, ePub and Kindle
Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.
Author | : Sarfaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 258 |
Release | : 2004-04-27 |
Genre | : Medical |
ISBN | : 1420048457 |
Download Handbook of Pharmaceutical Manufacturing Formulations Book in PDF, ePub and Kindle
The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Author | : Sarfaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 337 |
Release | : 2004-04-27 |
Genre | : Medical |
ISBN | : 9780849317507 |
Download Handbook of Pharmaceutical Manufacturing Formulations Book in PDF, ePub and Kindle
The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.
Author | : Dilip M. Parikh |
Publisher | : CRC Press |
Total Pages | : 905 |
Release | : 2021-05-11 |
Genre | : Medical |
ISBN | : 1000366383 |
Download Handbook of Pharmaceutical Granulation Technology Book in PDF, ePub and Kindle
Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies