Overview of “The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products”

References

1. International Organization for Standardization. ISO 14644 series, ISO: Geneva, 2017. https://www.iso.org/committee/54874/x/catalogue/ (accessed December 18, 2017).
2. U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
3. European Commission. Eudralex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2008.
4. Japan PDA Pharmaceutical Society. Manufacture of Non-Sterile Preparations: Study on Environmental Management, Construction of Maintenance/Management Method Based on Risk, Pharm Tech Japan, 2012, 28, (6); 49–65.