GMP Audits in Pharmaceutical and Biotechnology Industries PDF Download
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Author: Mustafa Edik
Publisher: CRC Press
ISBN: 1003814042
Category : Medical
Languages : en
Pages : 474
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Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Mustafa Edik
Publisher: CRC Press
ISBN: 1003814042
Category : Medical
Languages : en
Pages : 474
Get Book Here
Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Mustafa Edik
Publisher: Drugs and the Pharmaceutical Sciences
ISBN: 9781032257303
Category : Pharmaceutical industry
Languages : en
Pages : 0
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Book Description
This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as auditors in organizations that follow FDA, EMA, MHRA, WHO, TGA, PIC/S regulations.
Author: Pharmaceutical Quality Group
Publisher:
ISBN: 9780906810682
Category : Drugs
Languages : en
Pages : 56
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Book Description
Author: Mary O'Brien
Publisher: MIT Press
ISBN: 9780262650533
Category : Science
Languages : en
Pages : 310
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Book Description
This work recommends a simple yet profound shift to another decision-making technique: alternatives assessment. Instead of asking how much of a hazardous activity is safe, alternatives assessment asks how we can avoid or minimize damage.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
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: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author: Adalberto Pessoa Jr
Publisher: CRC Press
ISBN: 1040017665
Category : Medical
Languages : en
Pages : 539
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Book Description
This outstanding text focuses on providing professionals and students working in the pharmaceutical and biotechnology field with the background necessary for developing of a product or process and with the necessary rigor required by federal regulatory agencies in the pharmaceutical industry. The material will enable teachers, lecturers and professors in biotechnology to prepare courses on basic concepts and applications for the purification of biotechnological products of industrial interest. These can be applied in practice, for example, with projects on purification development on an industrial scale or useful unit operations for the development of bioproducts of commercial interest. Features: Purification and development of new bioproducts and improvement of those being produced Provides a background and concepts on the purification of biomolecules and with an industrial perspective It allows professionals to understand the entire process of developing a biopharmaceutical or bio-food, from bench to industry in biotechnology; one of the fastest-growing sectors of the economy It promotes the dissemination of information in a didactic way which is of paramount importance for interdisciplinary fields It enables the reader to follow step-by-step stages of the development of a new biopharmaceutical, and allows the optimization of existing processes
Author: Vikas Anand Saharan
Publisher: CRC Press
ISBN: 1040101658
Category : Medical
Languages : en
Pages : 519
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Book Description
Pharmaceutical researchers are constantly looking for drug products, drug delivery systems and devices for improving the health of society. A scientific and systematic search for new knowledge requires a thorough understanding of research methods and hypothesis design. This volume presents pharmaceutical research through theoretical concepts, methodologies and ethical issues. It fulfils publication ethics course work requirements for students. Chapters have been designed to cater for the curriculum requirements of universities globally. This serves as a guide on how to apply concepts in designing experiments and transforming laboratory research into actual practice. Features: · Complete coverage of research methodology courses for graduate and postgraduate students globally. · Step-by-step assistance in writing technical reports, projects, protocols, theses and dissertations. · Experimental designing in pharmaceutical formulation development and preclinical research designs. · Ethics in using animals in preclinical research and humans in clinical research. · Publication ethics, best practices and guidelines for ensuring ethical writing. · Hypothetical and real-world case studies on ethical issues and measures for prevention and control.
Author: Graham P. Bunn
Publisher: CRC Press
ISBN: 104016627X
Category : Medical
Languages : en
Pages : 189
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Book Description
Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted. Provides the most up‐to‐date and best practices, techniques, and methodologies in good clinical practice. Discusses applicable laws and regulations supporting GCP compliance, quality and operations. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.
Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 446
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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
