February 2019 | AsepticEnclosures

February 2019

Cleaning Program under the Revised Propositions

Cleaning Program under the Revised Propositions The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling. Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically …

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SOPs for USP Pharmacy

SOPs for USP Pharmacy

Achieving and maintaining SOPs for USP Pharmacy General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is a continuous effort that requires unremitting attention and maintenance, including staff training, performance review, documentation, and quality improvement efforts. Developing comprehensive policies and procedures (P&Ps) and standard operating procedures (SOPs) is critical to ensuring compliance with the chapter (see TABLE: Recommended …

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Trends in USP Compliance

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting …

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