Good Manufacturing Practices: Guide to Compliance -
Introducing a series of guides to the US and other major international regulations governing the 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.
Good Manufacturing Practices: Guide to Compliance, provides clear recommendations for performing chemistry, manufacturing and control activities according to 21CFR210 and 211, ICHQ7 and Annex 13. This Guide was recently updated and includes templates for SOPs and other forms that can be copied and used directly in the manufacturing environment, including a full set of GMP inspection sheets.
This 200+ page report will be available in electronic format and includes chapters and appendices covering the following information:
• Comparison of International GMP Regulations
• Regulatory Submission for CMC Data
• Critical Compliance Issues
• Validation of Systems, Process and Methods
• Internal and External Inspections and Audits
• Guide to Writing SOPs
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