Article Demo Title - Effective Strategies That Boost Productivity, Safety, Quality, and Compliance

References

1. FDA Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry. U.S. Food and Drug Administration. Mar. 1998
2. EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use. Annex 1: “Manufacture of Sterile Medicinal Products. European Medicines Agency.” 25 Nov. 2008.
3. Directive 2001/83/EC. Annex 1: Analytical Pharmacotoxicological and Clinical Standards and Protocols in Respect of the Testing of Medicinal Products. European Parliament. Nov. 2001
4. ISO 14698-1:2003. “Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods.” Sep. 2003.
5. ISO 14698-2:2003. “Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data.” Sep. 2003.
6. BS EN 17141:2020. “Cleanrooms and associated controlled environments. Biocontamination control.” 13 Aug. 2020.
7. BS EN 17272:2020. “Chemical disinfectants and antiseptics. Methods of airborne room disinfection by automated process.” 7 Apr. 2020.