QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL, API, AND BIOTECHNOLOGY BY SYED IMTIAZ HAIDER, ERFAN SYED ASIF
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QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL, API, AND BIOTECHNOLOGY BY SYED IMTIAZ HAIDER, ERFAN SYED ASIF PDF
Checking out practice will certainly consistently lead individuals not to completely satisfied reading Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif, a book, ten book, hundreds books, and more. One that will certainly make them feel completely satisfied is finishing reviewing this e-book Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif as well as obtaining the notification of guides, then finding the various other next publication to review. It continues increasingly more. The moment to finish reviewing a book Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif will certainly be always various depending upon spar time to invest; one instance is this Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif
About the Author Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and inprocess control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development. Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.
QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL, API, AND BIOTECHNOLOGY BY SYED IMTIAZ HAIDER, ERFAN SYED ASIF PDF
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QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL, API, AND BIOTECHNOLOGY BY SYED IMTIAZ HAIDER, ERFAN SYED ASIF PDF
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries.
The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.
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Sales Rank: #3657520 in Books Brand: Brand: CRC Press Published on: 2012-06-06 Original language: English Number of items: 1 Dimensions: 10.25" h x 7.00" w x 1.25" l, 2.65 pounds Binding: Hardcover 584 pages
Features ●
Used Book in Good Condition
About the Author Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and inprocess control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development. Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.
Most helpful customer reviews 0 of 0 people found the following review helpful. Good starting point for SOPs By Matt B Good starting point for SOPs, but I don't think it's very in line with current industry practice in the U.S. Having the CD is very nice for traveling consultants. See all 1 customer reviews...
QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL, API, AND BIOTECHNOLOGY BY SYED IMTIAZ HAIDER, ERFAN SYED ASIF PDF
It will certainly have no question when you are visiting choose this book. This motivating Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif publication can be reviewed totally in certain time relying on just how frequently you open up and also review them. One to keep in mind is that every publication has their very own production to obtain by each reader. So, be the excellent viewers and be a far better person after reviewing this e-book Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif About the Author Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and inprocess control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development. Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.
Checking out practice will certainly consistently lead individuals not to completely satisfied reading Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif, a book, ten book, hundreds books, and more. One that will certainly make them feel completely satisfied is finishing reviewing this e-book Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif as well as obtaining the notification of guides, then finding the various other next publication to review. It continues increasingly more. The moment to finish reviewing a book Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif will certainly be always various depending upon spar time to invest; one instance is this Quality Operations Procedures For Pharmaceutical, API, And Biotechnology By Syed Imtiaz Haider, Erfan Syed Asif
