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Author: Charles Nehme
Publisher: Charles Nehme
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 63
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Book Description
Preface for HVAC Site Acceptance Test for Pharmaceutical Plants Introduction The HVAC (Heating, Ventilation, and Air Conditioning) systems play a crucial role in pharmaceutical plants, ensuring that environmental conditions are tightly controlled to meet stringent regulatory requirements. The integrity of these systems directly impacts the quality and safety of pharmaceutical products. Therefore, a thorough and meticulously documented site acceptance test (SAT) is essential before commissioning any HVAC system in a pharmaceutical plant. Purpose The purpose of this document is to outline the procedures and criteria for conducting the HVAC site acceptance test (SAT) in pharmaceutical plants. The SAT ensures that the installed HVAC system operates according to the specified design, meets regulatory standards, and fulfills the requirements for maintaining controlled environments critical for pharmaceutical production. Scope This document covers the SAT procedures for HVAC systems, including testing methodologies, performance criteria, documentation requirements, and acceptance standards. It is intended for use by project managers, validation engineers, quality assurance personnel, and HVAC contractors involved in the commissioning and qualification of HVAC systems in pharmaceutical plants. Importance of HVAC Systems in Pharmaceutical Plants Environmental Control: HVAC systems maintain temperature, humidity, and air quality within specified ranges, essential for product stability and compliance with good manufacturing practices (GMP). Contamination Control: Properly functioning HVAC systems prevent cross-contamination and ensure a sterile environment, which is vital for the production of drugs and medical products. Regulatory Compliance: Compliance with regulatory standards, such as those set by the FDA, EMA, and other global health authorities, is mandatory for pharmaceutical plants. The SAT is a critical step in demonstrating that the HVAC system meets these stringent requirements. Product Quality: The consistent operation of HVAC systems is essential to ensure the quality and efficacy of pharmaceutical products. Any deviations can lead to compromised product integrity and potential recalls. Objectives The primary objectives of the HVAC SAT are: Verification of System Installation: Ensure that the HVAC system is installed according to design specifications and manufacturer guidelines. Operational Performance Testing: Validate that the HVAC system operates within specified parameters for temperature, humidity, airflow, and filtration. Compliance with Regulations: Confirm that the HVAC system meets all relevant regulatory standards and guidelines. Documentation and Reporting: Provide comprehensive documentation and reports to support the validation process and facilitate regulatory inspections. Structure of the Document This document is structured as follows: Preparation for SAT: Overview of pre-test preparations, including reviewing design specifications, regulatory requirements, and preparing test protocols. SAT Procedures: Detailed procedures for conducting the SAT, including test methods, instrumentation, and data collection. Performance Criteria: Specification of the performance criteria and acceptable limits for various parameters such as temperature, humidity, and airflow. Documentation Requirements: Guidelines for documenting the SAT process, including test results, deviations, and corrective actions. Acceptance and Approval: Criteria for acceptance and the process for approval by relevant stakeholders. Conclusion The HVAC site acceptance test is a critical component in the commissioning of pharmaceutical plants, ensuring that the environmental conditions necessary for product quality and regulatory compliance are met. This document provides a comprehensive framework for conducting the SAT, emphasizing the importance of meticulous testing and documentation to achieve a validated and reliable HVAC system.
Author: Charles Nehme
Publisher: Charles Nehme
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 63
Get Book Here
Book Description
Preface for HVAC Site Acceptance Test for Pharmaceutical Plants Introduction The HVAC (Heating, Ventilation, and Air Conditioning) systems play a crucial role in pharmaceutical plants, ensuring that environmental conditions are tightly controlled to meet stringent regulatory requirements. The integrity of these systems directly impacts the quality and safety of pharmaceutical products. Therefore, a thorough and meticulously documented site acceptance test (SAT) is essential before commissioning any HVAC system in a pharmaceutical plant. Purpose The purpose of this document is to outline the procedures and criteria for conducting the HVAC site acceptance test (SAT) in pharmaceutical plants. The SAT ensures that the installed HVAC system operates according to the specified design, meets regulatory standards, and fulfills the requirements for maintaining controlled environments critical for pharmaceutical production. Scope This document covers the SAT procedures for HVAC systems, including testing methodologies, performance criteria, documentation requirements, and acceptance standards. It is intended for use by project managers, validation engineers, quality assurance personnel, and HVAC contractors involved in the commissioning and qualification of HVAC systems in pharmaceutical plants. Importance of HVAC Systems in Pharmaceutical Plants Environmental Control: HVAC systems maintain temperature, humidity, and air quality within specified ranges, essential for product stability and compliance with good manufacturing practices (GMP). Contamination Control: Properly functioning HVAC systems prevent cross-contamination and ensure a sterile environment, which is vital for the production of drugs and medical products. Regulatory Compliance: Compliance with regulatory standards, such as those set by the FDA, EMA, and other global health authorities, is mandatory for pharmaceutical plants. The SAT is a critical step in demonstrating that the HVAC system meets these stringent requirements. Product Quality: The consistent operation of HVAC systems is essential to ensure the quality and efficacy of pharmaceutical products. Any deviations can lead to compromised product integrity and potential recalls. Objectives The primary objectives of the HVAC SAT are: Verification of System Installation: Ensure that the HVAC system is installed according to design specifications and manufacturer guidelines. Operational Performance Testing: Validate that the HVAC system operates within specified parameters for temperature, humidity, airflow, and filtration. Compliance with Regulations: Confirm that the HVAC system meets all relevant regulatory standards and guidelines. Documentation and Reporting: Provide comprehensive documentation and reports to support the validation process and facilitate regulatory inspections. Structure of the Document This document is structured as follows: Preparation for SAT: Overview of pre-test preparations, including reviewing design specifications, regulatory requirements, and preparing test protocols. SAT Procedures: Detailed procedures for conducting the SAT, including test methods, instrumentation, and data collection. Performance Criteria: Specification of the performance criteria and acceptable limits for various parameters such as temperature, humidity, and airflow. Documentation Requirements: Guidelines for documenting the SAT process, including test results, deviations, and corrective actions. Acceptance and Approval: Criteria for acceptance and the process for approval by relevant stakeholders. Conclusion The HVAC site acceptance test is a critical component in the commissioning of pharmaceutical plants, ensuring that the environmental conditions necessary for product quality and regulatory compliance are met. This document provides a comprehensive framework for conducting the SAT, emphasizing the importance of meticulous testing and documentation to achieve a validated and reliable HVAC system.
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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Book Description
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Author: Gary Prager
Publisher: John Wiley & Sons
ISBN: 0470410329
Category : Science
Languages : en
Pages : 578
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Book Description
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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Book Description
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author: Jeffery Odum
Publisher: John Wiley & Sons
ISBN: 1118833651
Category : Science
Languages : en
Pages : 381
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Book Description
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Author: Rick Ng
Publisher: John Wiley & Sons
ISBN: 1118210700
Category : Science
Languages : en
Pages : 368
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Book Description
"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
Author: Isaac Ghebre-Selassie
Publisher: CRC Press
ISBN: 0824755200
Category : Medical
Languages : en
Pages : 383
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Book Description
Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.
Author: Yvonne Bouwman-Boer
Publisher: Springer
ISBN: 3319158147
Category : Medical
Languages : en
Pages : 873
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Book Description
This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.
Author: Steven Ostrove
Publisher: Academic Press
ISBN: 0128175699
Category : Medical
Languages : en
Pages : 236
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Book Description
Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240086080
Category : Business & Economics
Languages : en
Pages : 1354
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Book Description
The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
