pharmaceutical manufacturing handbook

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Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
ISBN : 0470259809
Genre : Science
File Size : 66. 50 MB
Format : PDF, ePub
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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.

Handbook Of Pharmaceutical Manufacturing Formulations Second Edition

Author : Sarfaraz K. Niazi
ISBN : 9781420081176
Genre : Medical
File Size : 90. 49 MB
Format : PDF
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The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on. Highlights from Compressed Solid Products, Volume One include: formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition the essentials of what you need to be aware of when establishing a manufacturing process based on the formulations presented identification and inclusion of the most popular prescription products, a critical list for the selection of products

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
ISBN : 0470259825
Genre : Science
File Size : 26. 35 MB
Format : PDF, ePub, Docs
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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.

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
ISBN : 1420048457
Genre : Medical
File Size : 22. 21 MB
Format : PDF, Mobi
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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, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. 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 liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

Good Quality Practice Gqp In Pharmaceutical Manufacturing A Handbook

Author : Jordi Botet
ISBN : 9781681081144
Genre : Medical
File Size : 37. 20 MB
Format : PDF, Docs
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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. Close

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Safaraz K. Niazi
ISBN : 9781420081312
Genre : Medical
File Size : 89. 94 MB
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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 sterile products has evolved into a very sophisticated industry. Highlights from Sterile Products, Volume Six include: formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications specifications of a manufacturing facility to manufacture compliant sterile products NDA or aNDA filing requirements of sterile products an alphabetical presentation of formulations of pharmaceutical products based on their generic names

Pharmaceutical Manufacturing Handbook 2 Volume Set

Author : Shayne Cox Gad
ISBN : 0471213918
Genre : Science
File Size : 59. 4 MB
Format : PDF, Mobi
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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.

The Certified Pharmaceutical Gmp Professional Handbook Second Edition

Author : Mark Allen Durivage
ISBN : 9780873899338
Genre : Business & Economics
File Size : 29. 76 MB
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The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
ISBN : 9781420081275
Genre : Medical
File Size : 33. 1 MB
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The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations. Highlights from Semisolid Products, Volume Four include: coverage of over 350 formulations valuable information on the difficult area of compliance changes to approved new drug applications and abbreviated new drug applications the evolving guidelines of ICH and when to conduct a regulatory review

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
ISBN : 1135498601
Genre : Medical
File Size : 55. 29 MB
Format : PDF
Download : 506
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The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. 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 sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.

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