1. FDA (2006) Guidance for industry: Q9 quality risk management. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073511.pdf
2. FDA (2009) Guidance for industry: Q8(R2) pharmaceutical development. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf
3. FDA (2009) Guidance for industry: Q10 pharmaceutical quality system. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073517.pdf
4. FDA (2012) Guidance for industry: Q11 development and manufacture of drug substances. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf
5. FDA (1999) Guidance for industry Q6B specifications: test procedures and acceptance criteria for biotechnological/biological products. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073488.pdf