Quality Control Of Compounded Radiopharmaceuticals
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Quality Control of Compounded Radiopharmaceuticals
pharmacyce.unm.eduQUALITY CONTROL OF COMPOUNDED RADIOPHARMACEUTICALS Vivian S. Loveless, Pharm.D, BCNP, FAPhA Associate Professor Department of Pharmaceutical Sciences College of Pharmacy The University of Tennessee Health Science Center INTRODUCTION A radiopharmaceutical is only as good as the care taken in each preparation step throughout the …
NON-HAZARDOUS STERILE PREPARATIONS
napra.ca7. QUALITY ASSURANCE PROGRAM 55 7.1 Program content 55 7.2 Results and action levels 55 7.3 Verification of equipment and facilities 55 7.4 Quality assurance of personnel involved in aseptic compounding 60 7.5 Quality assurance of compounded sterile preparations 61 7.6 Documentation of quality control activities 62 8. SOURCE FOR ADDITIONAL ...
BRIEFING 797 Pharmaceutical Compounding—Sterile ...
www.usp.org14.1 Use of Compounded Single-Dose Containers. 14.2 Use of Compounded Stock Solutions 14.3 Use of Compounded Multiple-Dose Containers 15. QUALITY ASSURANCE AND QUALITY CONTROL 15.1 Notification About and Recall of Out-of-Specification Dispensed CSPs 15.2 Complaint Handling. 15.3 Adverse Event Reporting 16. CSP STORAGE, HANDLING, …
797 PHARMACEUTICAL COMPOUNDING—STERILE …
www.uspnf.comNov 22, 2019 · 16.1 Use of Compounded Multiple-Dose CSPs 16.2 Use of Compounded Single-Dose CSPs and CSP Stock Solutions 17. SOPs 18. QUALITY ASSURANCE AND QUALITY CONTROL 18.1 Notification About and Recall of Out-of-Specification Dispensed CSPs 18.2 Complaint Handling 18.3 Adverse Event Reporting 19. CSP HANDLING, STORAGE, …
Chapter 21-4.1.0 - Design Requirements for Compounded ...
www.ihs.govCompounded Sterile Preparation (CSP) - For the purposes of this chapter, CSPs include any of the following: (1) Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients: aqueous bronchial and nasal
General Chapters <797> Pharmaceutical Compounding ...
www.uspnf.comApr 24, 2020 · 1. Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients: aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections (e.g., colloidal dispersions, emulsions, solutions,
USP Chapters <797> and <800> New and Revised …
www.aha.orgdirector of pharmacy practice and quality, at mganio@ashp.org. American Society for Healthcare Risk Management (ASHRM) Considerations for Compliance It is essential that health care risk professionals have knowledge of USP <800> and its requirements for the protection of the health care worker from harm associated with exposure to hazardous drugs.
PE009, the PIC/S guide to GMP for medicinal products
www.tga.gov.auPE009, the PIC/S guide to GMP for medicinal products TGA interpretation and expectations for demonstrating compliance Version 2.1, September 2020