FDA 2011 Process Validation Guidance: Lifecycle Compliance Model

References

1. 1.↵
   FDA Guidance for Industry (Final). Process Validation: General Principles and Practices, January 2011; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf.
2. 2.↵
   FDA Guidance for Industry and Review Staff (Draft). Target Product Profile: A Strategic Development Process Tool, March 2007; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080593.pdf.
3. 3.↵
   FDA Guidance for Industry (Final). Q10 Pharmaceutical Quality System, April 2009; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073517.pdf.