1. Current Good Manufacturing Practice (CGMP) Regulations ‘U.S. Food and Drug Administration’ 2018.https://www.fda.gov/drugs/pharmaceutical‐quality‐resources/current‐good‐manufacturing‐practice‐cgmp‐regulations(accessed 18 February 2020).
2. Guidance Document ‘PAT – A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance’ 2018. September 2004 U.S. Food and Drug Administration https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/pat‐framework‐innovative‐pharmaceutical‐development‐manufacturing‐and‐quality‐assurance(accessed 18 February 2020).
3. FDA ‘Pharmaceutical CGMPs for the 21st Century – A Risk‐Based Approach’ 2004.https://www.fda.gov/media/77391/download
4. FDA ‘Guidance document – Q8(R2) Pharmaceutical Development’ 2009.https://www.fda.gov/media/71535/download
5. Use of Process Analytical Technology in Pharmaceutical Quality Control, ‐How Will Japan Respond to the Active Movements of Europe and the United States?;Kojima S.;Pharm. Tech. Jpn,2003