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 Laboratory Practices: Guide to Compliance, provides clear recommendations for performing preclinical laboratory studies according to 21CFR58 and the OECD Principles of Good Laboratory Practice. The Guide includes templates for SOPs and other forms that can be copied and used directly in the laboratory, including a full set of GLP inspection sheets.
This 100+ page report will be available in PDF format and includes chapters and appendices covering the following information:
- Comparison of International GLP Regulations
- Regulatory Submission for Preclinical Data
- Critical Compliance Issues
- Quality Assurance in R&D
- Internal and External Inspections and Audits
- SOP Templates
For bulk order pricing and options, please contact Adriana Randall at 781-972-5402.