Page 32 - ARNM-2-3
P. 32
Advances in Radiotherapy
& Nuclear Medicine QC parameters in radiopharmaceuticals
15. Radiopharmaceutical Preparations, Japanese Pharmacopoeia. 29. Sterility, The International Pharmacopoeia. 11 ed. Geneva:
th
18 ed.; 2021. World Health Organization; 2023.
th
16. Khurshid SJ, Sadiq MZ. Quality assurance in 30. Sterility Testing of Radiopharmaceuticals. Available from:
nuclear medicine--biological quality control of https://www.cup-freitag.de/en/radioster/sterile-testing-of-
radiopharmaceuticals. Pak J Pharm Sci. 1996;9(1):43-54. radiopharmaceuticals [Last accessed on 2023 Nov 20].
17. Maltby P, Liverpool (UK). Radiopharmacy Quality Control. 31. Indian Pharmacopoeia. Approach to Alternative
Available from: https://www.eanm.org/content-eanm/ Microbiological Methods. 9 ed. Ghaziabad: Indian
th
uploads/cte-archive/2009/cte-6/cte6_3.pdf [Last accessed Pharmacopoeia Commission; 2022.
on 2023 Nov 20].
32. Alternative Methods for Control of Microbiological Quality,
18. Radiopharmaceuticals: Directives 65/65/EEC, 75/318/EEC as British Pharmacopeia; 2023.
amended, Directive 89/343/EEC; 1990.
33. Validation of Alternative Microbiological Methods, United
19. Radiopharmaceuticals: Directives 65/65/EEC, 75/318/EEC as States Pharmacopeia. Rockville, MD: The United States
amended, Directive89/343/EEC; 1990. Pharmacopoeial Convention; 2022.
20. The International Pharmacopoeia. Radiopharmaceuticals 34. Arjun C, Karkhanis B, Korde AG. Bacterial Endotoxin
General Monograph, Working Document QAS/13.542/Rev.2; Testing of Injectable Radiopharmaceuticals: BRIT Experience.
2017. Available from: https://www.who.int/docs/default- Austria: International Atomic Energy Agency (IAEA);
source/medicines/norms-and-standards/current-projects/ 2020. Available from: https://inis.iaea.org/search/search.
qas13-542rev2-general-chapter-radiopharmaceuticals. aspx?orig_q=RN:52009402 [Last accessed on 2023 Nov 20].
pdf?sfvrsn=516dbf81_2 [Last accessed on 2023 Nov 20].
35. Bacterial Endotoxin, Indian Pharmacopoeia. 9 ed.
th
21. Loveless VS. Quality Control of Compounded Ghaziabad: Indian Pharmacopoeia Commission; 2022.
Radiopharmaceuticals. Vol. 15., Lesson 3. United States:
UNM College of Pharmacy; 2009. 36. Bacterial Endotoxin, British Pharmacopeia; 2023.
37. Bacterial Endotoxin, United States Pharmacopeia. Rockville,
22. Gillings N, Hjelstuen O, Ballinger J, et al. Guideline
on current good radiopharmacy practice (cGRPP) for MD: The United States Pharmacopoeial Convention; 2022.
th
the small-scale preparation of radiopharmaceuticals. 38. Bacterial Endotoxin, The International Pharmacopoeia. 11
EJNMMI Radiopharm Chem. 2021;6:8. ed. Geneva: World Health Organization; 2023.
doi: 10.1186/s41181-021-00123-2
39. Importance of the LAL Assay for Testing
23. Saha GB. Quality control of radiopharmaceuticals. In: Radiopharmaceuticals. Radiopharmaceuticals in Modern
Fundamentals of Nuclear Pharmacy. New York: Springer; 1998. Medicine. Available from: https://www.wakopyrostar.com/
doi: 10.1007/978-1-4757-2934-4_8 blog/kit-lal/post/importance-of-the-lal-assay-for-testing-
radiopharmaceuticals [Last accessed on 2023 Nov 20].
24. Wind K. The sterility testing of radiopharmaceuticals.
In: Radiopharmacy and Radiopharmacology Yearbook; 40. Rabbit Pyrogen Test, Indian Pharmacopoeia. 9 ed.
th
1985. Available from: https://www.taylorfrancis.com/ Ghaziabad: Indian Pharmacopoeia Commission; 2022.
chapters/edit/10.4324/9781315074771-2/sterility-testing- 41. Methods of Preparation of Sterile products, British
radiopharmaceuticals-kevin-wind [Last accessed on 2023 Pharmacopeia; 2023.
Nov 20].
42. GMP Guidelines Uncategorized. Parametric Release by API
25. Sharma S, Jain S, Baldi A, Singh RK, Sharma RK. FIRST0. Available from: https://www.apifirst.in/2020/12/08/
Intricacies in the approval ofradiopharmaceuticals - parametric-release [Last accessed on 2020 Dec 08].
regulatory perspectives and the way forward. Curr Sci.
2019;116(1):47-55. 43. Sharma S, Rajan MG, Baldi A, Singh RK, Sharma RK. The
regulatory dilemma for import of radiopharmaceuticals in
doi: 10.18520/cs/v116/i1/47-55
India. Curr Sci. 2019;116:1787-1789.
26. Sterility, Indian Pharmacopoeia. 9 ed. Ghaziabad: Indian 44. European Medicines Agency. Veterinary Medicines and
th
Pharmacopoeia Commission; 2022.
Inspections. In: Guideline on Parametric Release: EMEA/
27. Sterility, British Pharmacopeia. Ghaziabad: Indian CVMP/QWP/339588/2005-Consultation. London:
Pharmacopoeia Commission; 2023. Committee for Medicinal Products for Veterinary Use; 2006.
28. Sterility, United States Pharmacopeia. Rockville, MD: The 45. Parametric Release and Real-Time Release Testing.
United States Pharmacopoeial Convention; 2022. Pharmaceutical Technology; 2012.
Volume 2 Issue 3 (2024) 12 doi: 10.36922/arnm.3619

