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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures

Author(s):  Okeke Claudia C, Allen Loyd V Jr

Issue:  Nov/Dec 2009 - Geriatric Compounding
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Page(s):  546-553

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 1
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 2
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 3
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 4
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 5
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 6
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 7
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Page 8

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Abstract:  The standard operating procedures suggested in this article are presented to compounding pharmacies to ensure the quality of the environment in which a CSP is prepared. Since United States Pharmacopeia Chapter <797> provides minimum standards, each facility should aim for best practice gold standard. The standard operating procedures should be tailored to meet the expectations and design of each facility. Compounding personnel are expected to know and understand each standard operating procedure to allow for complete execution of the procedures.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, United States Pharmacopeia Chapter <797>, quality control, standard operating procedures, SOPs, sterile preparations, regulatory compliance, documentation, Claudia C. Okeke, PhD, RPh

Related Categories: SOPs, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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