Introducing a new series of guides to the US and international regulations governing the research, development, and manufacture of biotechnology and pharmaceutical products, commonly referred to as the 'GxP Regulations.' This series is intended to aid companies seeking information and practical advice on efficiently establishing full compliance with Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice.
These guides summarize the latest regulations and guidances issued by the FDA and the regulatory authorities in Canada, the European Union, and Japan; provide detailed analysis of these regulations; and provide practical advice and examples of how best to implement them. The aim of the guides is to provide simple and concise interpretation of these regulations and to provide effective solutions for their implementation in the development manufacturing, pilot plant, manufacturing facility, and clinical trial sites.
Good Clinical Practices: Guide to Compliance, provides clear recommendations for full compliance with global regulatory requirements. The Guide includes templates for SOPs and other forms that can be copied and used directly in the GCP environment, including a full set of GCP inspection sheets.
This report will be available in a PDF format and includes chapters and appendices covering the following information:
- Comparison of International GCP Regulations
- Regulatory Submission for GCP Data
- Critical Compliance Issues
- Internal and External Inspections and Audits
- SOP Templates
For bulk order pricing and options, please contact Adriana Randall at 781-972-5402.
Guide to Compliance: Good Clinical Practices, 5th Edition; Review by Norman M. Goldfarb