Download or read book Recommendation on Sterility Testing written by Pharmaceutical Inspection Convention and published by . This book was released on 2004 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Microbiology Manual written by United States Food and Drug Administration and published by Createspace Independent Publishing Platform. This book was released on 2017-09-21 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Filtration and Purification in the Biopharmaceutical Industry written by Maik J. Jornitz and published by CRC Press. This book was released on 2007-11-28 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in
Download or read book Filtration and Purification in the Biopharmaceutical Industry Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-09 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Download or read book Single Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2011-08-08 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts – the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence.
Download or read book Disposable Bioprocessing Systems written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, bioreactors, connectors and transfers, controls and sensors, downstream processing systems, filling and finishing systems, and filters. The author also shares his predictions for the future, calling disposable bioprocessing technology a "game changer."
Download or read book Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Isolators written by Brian Midcalf and published by Pharmaceutical Press. This book was released on 2004 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work considers the basic concepts, definitions, and standards necessary in the design, construction, commissioning, maintenance, and use of pharmaceutical isolators.
Download or read book Pharmaceutical Dosage Forms written by Sandeep Nema and published by CRC Press. This book was released on 2010-08-26 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products
Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-01-05 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th
Download or read book Scientific Criteria to Ensure Safe Food written by National Research Council and published by National Academies Press. This book was released on 2003-09-29 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food safety regulators face a daunting task: crafting food safety performance standards and systems that continue in the tradition of using the best available science to protect the health of the American public, while working within an increasingly antiquated and fragmented regulatory framework. Current food safety standards have been set over a period of years and under diverse circumstances, based on a host of scientific, legal, and practical constraints. Scientific Criteria to Ensure Safe Food lays the groundwork for creating new regulations that are consistent, reliable, and ensure the best protection for the health of American consumers. This book addresses the biggest concerns in food safetyâ€"including microbial disease surveillance plans, tools for establishing food safety criteria, and issues specific to meat, dairy, poultry, seafood, and produce. It provides a candid analysis of the problems with the current system, and outlines the major components of the task at hand: creating workable, streamlined food safety standards and practices.
Download or read book Regenerative Medicine written by Gustav Steinhoff and published by Springer Science & Business Media. This book was released on 2013-03-20 with total page 1211 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of regenerative medicine has developed rapidly over the past 20 years with the advent of molecular and cellular techniques. This textbook, Regenerative Medicine: From Protocol to Patient, aims to explain the scientific knowledge and emerging technology as well as the clinical application in different organ systems and diseases. International leading experts from four continents describe the latest scientific and clinical knowledge of the field of regenerative medicine. The process of translating science of laboratory protocols into therapies is explained in sections on regulatory, ethical and industrial issues. This textbook is organized into five parts: (I) Biology of Tissue Regeneration, (II) Stem Cell Science and Technology, (III) Tissue Engineering, Biomaterials and Nanotechnology, (IV) Regenerative Therapies and (V) Regulation and Ethics. The textbook aims to give the student, the researcher, the health care professional, the physician and the patient a complete survey on the current scientific basis, therapeutical protocols, clinical translation and practiced therapies in regenerative medicine.
