Regulatory Guidance Links
1. Main FDA Website
2. Title 21 Electronic Code of Federal Regulations
3. Guidance Documents (drugs)
4. Recent Final Medical Device Guidance Documents
5. Guidance, Compliance & Regulatory Information (Biologics)
6. Guidance for Industry (Animal & Veterinary)
Hot Topics
1. Data Integrity and Compliance with cGMP
2. Serialization (Drug Supply chain Security Act)
Who We Are
Validation and Automation Expertise
Special Topics
2. Guideline on process validation for finished products – information and data to be provided in regulatory submissions. European Medicines Agency
3. Guide to Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. US Department of Health and Human Services Food and Drug Administration. Process Validation: General Principles and Practices
4. Guidelines on Validation – Appendix 5 Validation of Computerized Systems
1. Good Distribution Practice of Medicinal Products for Human Use. European Commission Guidelines of 5 November 2013
2. Principles of Good Distribution Practice of Active Substances for Medical Products for Human Use. European Commission Guidelines of 19 March 2015.
3. PIC/S Guide to Good Distribution Practice for Medicinal Products. PIC/S June 2014
4. Supply Chain Security Toolkit. Asia-Pacific Economic Cooperation (APEC)
