1. EMA, 2012. Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), 2012. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-real-time-release-testing-formerly-guideline-parametric-release-revision-1_en.pdf (Accessed 25.04.2023).
2. FDA, 2004. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 2004. https://www.gmp-compliance.org/files/guidemgr/PAT-FDA-6419fnl.pdf. (Accessed 25.04.2023).
3. FDA/ICH., 2006. Guidance for industry. Q8 pharmaceutical development, 2006. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development. (Accessed 25.04.2023).
4. FDA, 2019. Quality Considerations for Continuous Manufacturing Guidance for Industry. In: 2019. https://www.federalregister.gov/documents/2019/02/27/2019-03413/quality-considerations-for-continuous-manufacturing-draft-guidance-for-industry-availability. (Accessed 25.04.2023).
5. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US;Fisher;Int. J. Pharm.,2022