This bundle brings together three essential books on the USA regulatory requirements for the discovery/development, clinical determination and production/testing of pharmaceutical products: Good Laboratory Practice for Nonclinical Studies, Good Clinical Practices in Pharmaceuticals, and the new eighth edition of Good Manufacturing Practices for Pharmaceuticals. It is a valuable resource for those with responsibilities for complying with the USA Code of Federal (CFR) regulatory requirements for good laboratory, clinical, and manufacturing practices for clinical trial and marketed pharmaceuticals in the United States.
The bundle is ideal for start up companies and those that wish to broaden their knowledge and career of this fascinating industry.
Good Laboratory Practice for Nonclinical Studies
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.
Key Features:
- Unique volume covering FDA inspections of GLP facilities
- Provides a detailed interpretation of GLP Regulations
- Presents the latest on electronic data management in GLP
- Describes GLP and computer systems validation
- Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Good Clinical Practices in Pharmaceuticals
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.
Key Features:
- 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.
Good Manufacturing Practices for Pharmaceuticals, Eighth Edition
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
- Presents insight into the world of pharmaceutical quality systems.
- Analyzes regulatory trends and expectations.
- Includes approaches and practices used in the industry to comply with regulatory requirements.
- Discusses recent worldwide supply chain issues.
- Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry.
Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology and other FDA related industries in quality systems, regulatory action (FDA483, Warning Letter, Consent Decree) remediations and training. Before founding GB Consulting LLC, Graham gained extensive good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate compliance quality auditor and also in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide including Aseptic Training Programs, Batch Record Reviews, QA on the Floor and aseptic training support for 503B Compounding Centers. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and author of several book chapters and journal articles. Graham received a BSc in pharmacy from Brighton University, England, and a MSc in quality assurance and regulatory affairs from Temple University, Philadelphia and is a member of the Regulatory Affairs Professional Society (RAPS).
