Current Good Manufacturing Practice (cGMP): Pharmaceuticals

Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally.

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Offering a wide assortment of illustrative examples and 483 expert observations, this Sixth Edition is significantly expanded to reflect the explosion of information and changing practices in cGMP regulation and pharmaceutical manufacturing and control. An essential companion for every pharmaceutical professional, this guide supplies new and must-have information on system audits, electronic records and signatures, PAT applications, failure investigations, FDA enforcement tools, global regulatory changes, contracting and outsourcing, and the latest FDA guidance documents.

Bridging the gap between US and European Good Manufacturing Practice guidelines, this book comparatively presents the major substance of both the "US Current Good Manufacturing Practice for Finished Pharmaceutical Regulations" and the European "Guide to Good Manufacturing Practice for Medicinal Products."

Everything you need to ensure full compliance and superior quality control 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, all familiar with the many issues involved in compliance and quality control, offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods. Features: Discusses how packaging is designed and integrated into the product development cycle Provides an overview of the regulatory environment procedures.

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry...

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.

Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams.

Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.