APTCE Exam Reference Materials

 Exam References

1. Centers for Disease Control and Prevention (CDC). Core Concepts for Hand Hygiene: Clean Hands for Healthcare Personnel. Published 2024. 
2. European Commission, Directorate-General for Health and Food Safety. EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. Directorate-General for Health and Food Safety. Published 2022. 
3. Groves MJ, Murty R. Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s. CRC Press; 1995. 
4. Drexler M. What You Need to Know About Infectious Disease. National Academies Press; 2010. 
5. International Organization for Standardization (ISO). ISO 14644: Cleanrooms and Associated Controlled Environments. Published 2015. 
6. Occupational Safety and Health Administration (OSHA).
   • 29 CFR Part 1910.120: Hazardous waste operations and emergency response. 
   • 29 CFR 1910.134: Respiratory protection. 
   • 29 CFR 1910.332: Training. Published 1990. 
7. U.S. Food and Drug Administration (FDA).
   • Code of Federal Regulations Title 21, Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. Published 2024. 
   • Guidance for Industry: Data Integrity and Compliance with CGMP. Published 2018. 
   • Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. Published 2004. 
8. United States Pharmacopeia (USP). USP General Chapter <797>: Pharmaceutical Compounding—Sterile Preparations. Published 2023.