Compounding sterile medicines

References

  1. Sansom LN ed. Australian pharmaceutical formulary and handbook. 26th edn. Canberra: Pharmaceutical Society of Australia; 2024.
  2. Pharmacy Board of Australia. Guidelines on compounding of medicines. At: www.pharmacyboard.gov.au/Codes-Guidelines.aspx
  3. United States Pharmacopoeial Convention. USP-NF compounding compendium. 2023.
  4. Therapeutic Goods Administration. Good manufacturing practice – an overview. 2017. At: www.tga.gov.au/good-manufacturing-practice-overview
  5. European Medicines Agency. Guideline on Real Time Release Testing (formerly Guideline on Parametric Release). 2012. At: www.tga.gov.au/resources/resource/international-scientific-guidelines/international-scientific-guidelines-guideline-real-time-release-testing-formerly-guideline-parametric-release
  6. American Society for Quality. Failure mode and effects analysis (FMEA). At: https://asq.org/quality-resources/fmea
  7. Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments and relevant annexes (PE010).
  8. Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Guide to Good Manufacturing Practice for Medicinal Products and relevant annexes (PE009).
  9. Whyte W, Derks M. Airborne particle deposition in cleanrooms: relationship between deposition rate and airborne concentration. Clean Air and Containment Review. 2016;25:4–10.
  10. Victorian Pharmacy Authority. Victorian Pharmacy Authority Guidelines 2023. At: www.pharmacy.vic.gov.au/
  11. Pharmacy Regulation Authority SA. Guidelines for the operation of pharmacy premises by pharmacy services providers 2018. At: www.pharmacyauthority.sa.gov.au/
  12. Lund W, ed. The pharmaceutical codex. 12thedn. London: Pharmaceutical Press;1994.
  13. British Pharmacopoeia Commission. British Pharmacopoeia. London: BPC; 2023.