PDA Technical Report No. 39 (Revised 2007) PDF Download
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Author: PDA
Publisher:
ISBN: 9780939459186
Category :
Languages : en
Pages :
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Book Description
Author: PDA
Publisher:
ISBN: 9780939459186
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: PDA
Publisher:
ISBN: 9780939459117
Category :
Languages : en
Pages :
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Book Description
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.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 16
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Book Description
Author:
Publisher: World Health Organization
ISBN: 9240015434
Category : Medical
Languages : en
Pages : 169
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Book Description
International shipping of vaccines is the first leg of the complex journey that vaccines undertake to reach the end users in a country. Particular challenges include the size and weight of packages, implementation of quality control checks at reception, ensuring environmental sustainability, and maintaining required temperatures during the journey. Although there are many possibilities of transport e.g. sea freight and terrestrial transportation, air freight currently remains the most widely used means of transport for vaccines. In recognition of this fact, these guidelines apply predominantly to the air freighting of vaccines. Transportation of vaccines from the manufacturing facility to the airport facility require the use of ground transportation, and reference is also made to the qualification of refrigerated road vehicles as well. The objective of these guidelines is to provide technical guidance to help ensure the quality of vaccines during all stages of the international air transportation process. These guidelines are applicable to all persons and institutions involved in international air shipment of vaccines from the premises of the product manufacturer to the recipient country. This includes all parties involved in shipment, vaccine manufacturers, logistics service providers (LSPs), freight forwarders, carriers and their employees. The relevant sections of these guidelines should also be considered for implementation by UN procurement agencies and other international procurement organizations, countries, donor agencies and certifying bodies.
Author: Sandeep Nema
Publisher: CRC Press
ISBN: 042957472X
Category : Business & Economics
Languages : en
Pages : 2756
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Book Description
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Author:
Publisher:
ISBN:
Category : Electronic journals
Languages : en
Pages : 452
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Book Description
Author: Sandeep Nema
Publisher: CRC Press
ISBN: 1482281783
Category : Medical
Languages : en
Pages : 1168
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Book Description
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
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
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Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Author: Manmohan Singh
Publisher: John Wiley & Sons
ISBN: 1118023633
Category : Medical
Languages : en
Pages : 378
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Book Description
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.
