Quality Operations Procedures For Pharmaceutical Api And Biotechnology
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Quality Operations Procedures For Pharmaceutical Api And Biotechnology
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2012-06-06
Quality Operations Procedures For Pharmaceutical Api And Biotechnology written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-06 with Medical categories.
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-
Quality Operations Procedures For Pharmaceutical Api And Biotechnology
DOWNLOAD
Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2012-06-06
Quality Operations Procedures For Pharmaceutical Api And Biotechnology written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-06 with Medical categories.
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.
Quality Control Training Manual
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Quality Control Training Manual written by Syed Imtiaz Haider 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.
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Validation Standard Operating Procedures
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2006-05-30
Validation Standard Operating Procedures written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-05-30 with Medical categories.
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
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.
Biotechnology
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Author : Kenneth E. Avis
language : en
Publisher: CRC Press
Release Date : 2020-04-22
Biotechnology written by Kenneth E. Avis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-22 with Medical categories.
Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.
Modern Aspects Of Pharmaceutical Quality Assurance
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Author : Minal Ghante
language : en
Publisher: Springer Nature
Release Date :
Modern Aspects Of Pharmaceutical Quality Assurance written by Minal Ghante and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Quality Assurance Compliance
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Author : Ira C. Peine
language : en
Publisher:
Release Date : 1994
Quality Assurance Compliance written by Ira C. Peine and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Biotechnology categories.
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.
Quality Systems And Controls For Pharmaceuticals
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Author : Dipak Kumar Sarker
language : en
Publisher: John Wiley & Sons
Release Date : 2008-07-31
Quality Systems And Controls For Pharmaceuticals written by Dipak Kumar Sarker and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-07-31 with Science categories.
Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.